Information on the product

Size: px
Start display at page:

Download "Information on the product"

Transcription

1 Information on the product Information on the product -Implantat.doc Page 1 of 15

2 This document composes of the following items 1. Name of the product 2. Raw materials 3. Structure and dimensions 3.1. External specific Fixture Cover screw 3.2. External appearance and structure Product picture and explanation of the fixture Product picture and explanations of the cover screw surface fixture surface cover screw 4. Fatigue Tests on Endosseous Dental Implants 5. Manufacturing process 5.1. Flowing chart of manufacturing process 5.2. Sterilization method 5.3. Package 6. Purpose of the product 7. Operating procedure 8. Test names, standards, methods and results Information on the product -Implantat.doc Page 2 of 15

3 1. Name of the product Artikel Nr. Name / Bezeichnung Medical device class Titanium screw implants Europa Material Implant S3,25 L8,5 2b TI Grade Implant S3,25 L10 2b TI Grade Implant S3,25 L11,5 2b TI Grade Implant S3,25 L13 2b TI Grade Implant S3,25 L15 2b TI Grade Implant S3,75 L8,5 2b TI Grade Implant S3,75 L10 2b TI Grade Implant S3,75 L11,5 2b TI Grade Implant S3,75 L13 2b TI Grade Implant S3,75 L15 2b TI Grade Implant S3,75 L18 2b TI Grade Implant S4,5 L7 2b TI Grade Implant S4,5 L8,5 2b TI Grade Implant S4,5 L10 2b TI Grade Implant S4,5 L11,5 2b TI Grade Implant S4,5 L13 2b TI Grade Implant S4,5 L15 2b TI Grade Implant S4,5 L18 2b TI Grade Implant S5,5 L8,5 2b TI Grade Implant S5,5 L10 2b TI Grade Implant S5,5 L11,5 2b TI Grade Implant S5,5 L13 2b TI Grade Implant Cover Screw S3,25 2b TI Grade Implant Cover Screw S3,75 2b TI Grade Implant Cover Screw S4,5 2b TI Grade Implant Cover Screw S5,5 2b TI Grade 4 Information on the product -Implantat.doc Page 3 of 15

4 2. Raw materials item Raw material name (Standard) Composition (%) Fe O N C H AL V Ti Implant Unalloyed titanium, Ti Gr4 (fixture) ASTM F67 0,5 0,4 0,05 0,1 0, Rest *Cover screw Unalloyed titanium, Ti Gr4 ASTM F67 Oxidized film : TiO 2 0,5 0,4 0,05 0,1 0, Rest * Any raw materials are not included in the color of the fixture head part. Color-coded : Each cover screw was color-coded by its diameter. Color code was added by electrical method, not by pigment addition. Change of the oxidized film through electrical method made its different colors of fixture head and cover screw. Table cover screw : diameter / color diameter colour Implant Cover Screw S3,25 green Implant Cover Screw S3,75 blue Implant Cover Screw S4,5 red Implant Cover Screw S5,5 yellow Information on the product -Implantat.doc Page 4 of 15

5 3. Structure and dimensions 3.1 External specification Fixture (1) diameter of fixture s platform : see implant overview S3,25-S5,5 (2) entire length of fixture : see implant overview S3,25-S5,5 (3) Fixture surface : Pure titanium (grade4) with an osteoconductive micro structured, uncoated surface (4) Shape of fixture : a) Internal thread for fixed-removable restorations b) Internal hex (2.5 mm Hex) to prevent rotation of the superstructure elements c) Internal cone design for perfect gap-free seating of the restorative components d) Optimal for maintaining good oral hygiene e) Narrow high-polish shoulder (5) Color code: The abutments for the fixture were color-coded for easy distinguishment. Color code was added by electrical method, not by pigment addition. Change of the oxidized film through electrical method made its different colors of the abutments. Information on the product -Implantat.doc Page 5 of 15

6 3.1.2 Cover screw (1) diameter of cover screw cap : 5.5mm, 4.1mm, 3.7mm (2) entire length of cover screw : 6.45mm, 5.8mm, 5,5mm (3) color code : Each cover screw has a color corresponding to the diameter of the implant which connect with. Implant size Implant S3,25 Implant S3,75 Implant S4,5 Implant S5,5 Color of the cover screw green blue red yellow Information on the product -Implantat.doc Page 6 of 15

7 3.2 External appearance and structure Product picture and explanations of the fixture Prosthetic connection Narrow high-polish shoulder Surface characteristics Information on the product -Implantat.doc Page 7 of 15

8 3.2.2 Product picture and explanations of the cover screw Each cover screw has a color corresponding to the diameter of the implant which connect with. Implant size Implant S3,25 Implant S3,75 Implant S4,5 Implant S5,5 Color of the cover screw green blue red yellow Information on the product -Implantat.doc Page 8 of 15

9 3.2.3 Surface Fixture Pure titanium (Grade 4) Surface osteoconductive microstructure Surface uncoated Measured mean surface roughness of 4 µm Surface produce with a special bio-inert material through a material-removing blasting technique Surface cover screw Pure titanium (Grade 4) Surface uncoated Oxidized titanium treatment Thickness of oxidized film : less than 10 μm 4. Fatigue Tests on Endosseous Dental Implants a. Test Report A4.2-44e/97 b. Test Report A4.2-45e/97 c. Test Report LB1.3-19e/2003 Precisely conditions and results are described in the annex. Implant size Load application Load profile Load angle Embedding deph Environment Test period Information on the product -Implantat.doc Page 9 of 15

10 5. Manufacturing process Information on the product -Implantat.doc Page 10 of 15

11 6. Purpose and Features of the product (1) Capability ~~~~~~ (2) Purpose on usage or effect Fixture for dental implant surgery 7. Operating procedure (1) Preparation before use See manual for Implant Surgery. (2) Operating procedure See instruction manual (3) Storage method after use Do not re-use. (3) Storage method and the period of validity(shelf life-caution) The SEMADOS-Implant must be kept dry, dark and at room temperature in their original Storage Container. The implants may not used after their dates of expiry indicated on the label. Packaging and Sterility The SEMADOS Implants come in a packaging system made up of following components (outside in): Storage container (box with product package insert) Sealed secondary packaging (hard plastic container with peel-off adhesive label for patient file Sterile primary packaging (glass) for implant and cover screw Shelf life The period of validity is 5 years. Information on the product -Implantat.doc Page 11 of 15

12 Picture of the packaging Information on the product -Implantat.doc Page 12 of 15

13 Product and packaging test method No Test method Period Standard 1 Sterilization of health care Routine ISO products -- Requirements for examination validation and routine control -- Radiation sterilization 2 Sterilization of health care products -- Radiation sterilization -- Substantiation of 25 kgy as a sterilization dose for small or infrequent production batches 3 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques Routine examination Routine examination ISO/TS DIN EN General requirements for the Routine competence of testing and examination calibration laboraties 5 Biological evaluation of medical Routine devices - Part 5: Tests for in vitro examination cytotoxicity (ISO :1999) 6 LAL-Test Routine Limulus amebocyte lysate (LAL) examination 7 Bioburden and Sterility Testing Routine examination DIN EN ISO/IEC ISO Information on the product -Implantat.doc Page 13 of 15

14 8. Test names, standards, methods, and results. Test Test name Test standard Test method # Test for Physical and mechanical features 1 Testing of material Chemical composition of the implant and the other X-Ray Photoelectron Spectroscopy (XPS) parts should be as Surface Microanalyses (EDX) claimed. 2 Bare eye Surface of products must Microscope and magnifier inspection be covered matt finish inspection only the shoulder of the implant should be high pollished. There must be no cracks and any defects on usage. And it do not have to be covered any alien substances 3 Packing Sealing part in the Bare eye inspection inspection packaging must be sealed up and keep the inner part from being infected. 4 Dimension test Dimensions must be as Measure with measuring shown in the drawings. apparatus (Microscope, micrometer, caliper) 5 Fatigue test No cracks and fractures Take an bending fatigue test must be shown through with using fatigue test microscope. And any apparatus. loosening problems do not have to occur. E.g. Load profile: sinus, pulsating load Upper load: 296N±3N Max N of cycles: 2x10 6 Load angle: 30 against Information on the product -Implantat.doc Page 14 of 15

15 implant axis Embedding depth: embedded until 3 mm below upper implant end Environment: Ringer`s solution, 37 C Test for biological features 1 Transplantation No inflammations and According to ISO test dead cells must be shown (1994) in tissue around test objects 2 Acute virulence Any abnormal reactions See above test must not occur in any case (Product and packaging test (not into oral: of test under the following method) I.V. route) conditions. -Observe it right after injection -After injection, observe it at an interval of 1, 3, 24, 48, 72 hours and 7 days. 3 Exothermicity test It must be suited to test pyrogen test method at the time of test See above (Product and packaging test method) 4 Cellular virulence It must be less than mild According to ISO test standard when the 5(1992) contrast between positivity See above and negativity is accurate. (Product and packaging test method) Information on the product -Implantat.doc Page 15 of 15

ABOUT US. The Complete and Comprehensive solution for implants! Edison Medical. Edison Medical s Quality Strategy:

ABOUT US. The Complete and Comprehensive solution for implants! Edison Medical. Edison Medical s Quality Strategy: IMPLANTS CATALOG ABOUT US Edison Medical The Complete and Comprehensive solution for implants! Edison Medical Ltd. is engaged in the import, export, marketing and distribution of dental Implants and other

More information

Guidance for implant removal. Straumann Dental Implant System

Guidance for implant removal. Straumann Dental Implant System Guidance for implant removal Straumann Dental Implant System The ITI (International Team for Implantology) is academic partner of Institut Straumann AG in the areas of research and education. ContentS

More information

Contents. Cement retained restoration. Screw retained restoration. Overdenture retained restoration. TS Implant System. 70 ComOcta Gold Abutment

Contents. Cement retained restoration. Screw retained restoration. Overdenture retained restoration. TS Implant System. 70 ComOcta Gold Abutment Contents TS Implant System Cement retained restoration Screw retained restoration 06 Cement-retained bridges with the Solid abutment system (non- 72 Screw retained crown with the ComOcta Gold abutment

More information

NARROW DIAMETER implant

NARROW DIAMETER implant ND NARROW DIAMETER implant TABLE OF CONTENTS ND - NARROW DIAMETER implant Implant characteristics page 04 Dental implant page 05 Open Tray Impression Transfer page 06 Titanium Abutments page 07 O-Ball

More information

Standard Internal Hex

Standard Internal Hex Standard Internal Hex Touareg TM -OS Touareg TM -S Swell TM Touareg -S Touareg -OS Swell About ADIN Adin Dental Implant Systems Ltd., designs, manufactures and markets state of the art, technologically

More information

LIST OF INTERNATIONAL STANDARDS FOR MEDICAL DEVICES

LIST OF INTERNATIONAL STANDARDS FOR MEDICAL DEVICES NO STANDARD DESCRIPTION 1. ISO 13485: 2003 Medical Devices: Quality Management System: Requirements For Regulatory Purposes 2. EN540 Clinical Investigation of Medical Devices For Human 3. EN285 Sterilization

More information

Contact: Steve Hurson VP, R & D Nobel Biocare 22715 Savi Ranch Pkwy Yorba Linda, CA 92887 (714) 282-5072 steve.hurson@nobelbiocare.

Contact: Steve Hurson VP, R & D Nobel Biocare 22715 Savi Ranch Pkwy Yorba Linda, CA 92887 (714) 282-5072 steve.hurson@nobelbiocare. Use of CP Titanium and Titanium alloys for Dental Implants Steve Hurson, Nobel Biocare U.S.A. Yorba Linda CA Abstract Professor Per Ingvar Branemark of Sweden published his results on 15 years of research

More information

European Norms (EN) and/or International Standards (ISO) for sterilizers, packaging material, sterilization monitoring and validation

European Norms (EN) and/or International Standards (ISO) for sterilizers, packaging material, sterilization monitoring and validation 1. ISO/TS 11139 Terms and definitions in sterilization standards 2. EN ISO 11138 Biological indicators to test sterilization processes Part I General requirements for ethylene oxide sterilization (strips

More information

páêçå~=aéåí~ä=`^al`^j=póëíéã på~åmçëí

páêçå~=aéåí~ä=`^al`^j=póëíéã på~åmçëí kéï=~ë=çñw= MRKOMNP páêçå~=aéåí~ä=`^al`^j=póëíéã på~åmçëí lééê~íáåö=fåëíêìåíáçåë båöäáëü=erpf Operating Instructions = Sirona Dental Systems GmbH Table of contents 1 Symbols used... 3 2 Product description...

More information

Dental Morelli Ltda.

Dental Morelli Ltda. K Dental Morelli Ltda. JAN 82014 OR TOOON tia SECTION 7 510(k) SUMMARY Proprietary Name Orthodontic Miniscrew for Absolute Anchorage Date Prepared December 1, 2013 Submitter Official Contact DENTAL MORELLI

More information

BASIC INFORMATION ON THE STRAUMANN VARIOBASE ABUTMENT. Straumann Variobase Abutment

BASIC INFORMATION ON THE STRAUMANN VARIOBASE ABUTMENT. Straumann Variobase Abutment BASIC INFORMATION ON THE STRAUMANN VARIOBASE ABUTMENT Straumann Variobase Abutment 1 The ITI (International Team for Implantology) is academic partner of Institut Straumann AG in the areas of research

More information

MAY 2 1 2913. Attachment4. 5 10(k) Summary 21 CER 872.3640

MAY 2 1 2913. Attachment4. 5 10(k) Summary 21 CER 872.3640 MAY 2 1 2913 Traditional 510(k) Submission DIO tjf HSA Internal Sub-Merged Implant System Attachment4 5 10(k) Summary This summary of 5 10(K) safety and effectiveness information is being submitted in

More information

Basic information on the. Straumann Variobase Abutment.

Basic information on the. Straumann Variobase Abutment. Basic information on the Straumann Variobase Abutment. 1 Straumann is the industrial partner of the ITI (International Team for Implantology) in the areas of research, development, and education. Contents.

More information

Convertible Abutment. Introduction. Prosthetic Flow Diagram for GS Convertible Abutment. Configuration of GoldCast Cylinder

Convertible Abutment. Introduction. Prosthetic Flow Diagram for GS Convertible Abutment. Configuration of GoldCast Cylinder Prosthetic Flow Diagram for GS Cement & Screw & Combination Retained Restoration for Mini, Regular, Wide - Abutment Level Impression Taking Introduction Cylinder Screw(WCC) Three types of cylinder (combination,

More information

March 20, 2015. Dear Mr. Chen:

March 20, 2015. Dear Mr. Chen: DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 March 20, 2015 Biomate

More information

Implant materials. Learning outcomes. Implant materials in trauma. How to use this handout? Functions of implants. Types of materials

Implant materials. Learning outcomes. Implant materials in trauma. How to use this handout? Functions of implants. Types of materials Implant materials How to use this handout? The left column is the information as given during the lecture. The column at the right gives you space to make personal notes. Learning outcomes At the end of

More information

DESS. Screws. Tijuana Ventas: (664) 685 6294/95 hirambogarin@dabocorp.com. For all major implant systems!! www.dabocorp.com

DESS. Screws. Tijuana Ventas: (664) 685 6294/95 hirambogarin@dabocorp.com. For all major implant systems!! www.dabocorp.com Screws Screws for definitive use. Made from medical grade 5 ELI Titanium Integrity and soundness guaranteed by stress tests of up to 150% of their nominal torques. Their designs ensure a perfect fit with

More information

Dentistry Fatigue test for endosseous dental implants. Report No.: 1 ASTRA System Ti Design

Dentistry Fatigue test for endosseous dental implants. Report No.: 1 ASTRA System Ti Design Dentistry Fatigue test for endosseous dental implants Report No.: 1 ASTRA System Ti Design Client: NT - Trading Time of execution: Mai 2011 Subject of work: - - S - 24285 Abutment Ti DesignTM - RESULTS

More information

Integra. Large Qwix - Fixation and Positioning Screw SURGICAL TECHNIQUE

Integra. Large Qwix - Fixation and Positioning Screw SURGICAL TECHNIQUE Integra Large Qwix - Fixation and Positioning Screw SURGICAL TECHNIQUE Table of contents Indications... 03 Contraindications... 03 Description... 03 Instruments... 04 Fixation Screws... 04 Step 1: Positioning

More information

Implant Systems MAX LOGIC MONO. Today s name in tomorrow s implant technology

Implant Systems MAX LOGIC MONO. Today s name in tomorrow s implant technology Implant Systems MAX LOGIC MONO Today s name in tomorrow s implant technology Implant Systems Etgar Medical Implant Systems brings to the market an entire spectrum of dental implant products based on its

More information

Standardportfölj Kommittén för Sterilisering av medicintekniska produkter SIS/TK 349

Standardportfölj Kommittén för Sterilisering av medicintekniska produkter SIS/TK 349 CEN ISO/TS 11135-2:2008 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008) CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part

More information

Restoration of a screw retained single tooth restoration in the upper jaw with Thommen Titanium base abutment.

Restoration of a screw retained single tooth restoration in the upper jaw with Thommen Titanium base abutment. Restoration of a screw retained single tooth restoration in the upper jaw with Thommen Titanium base abutment. Dr. med. dent. David McFadden, Dallas County, USA Initial situation (single X-ray) Tooth 16

More information

TIGER Drylac U.S.A., Inc. 3855 Swenson Avenue St Charles, IL T 800 243 8148 F 877 926 8148 office.us@tiger-coatings.us www.tiger-coatings.

TIGER Drylac U.S.A., Inc. 3855 Swenson Avenue St Charles, IL T 800 243 8148 F 877 926 8148 office.us@tiger-coatings.us www.tiger-coatings. Product Data Sheet SERIES 69 - DRYZINC ZINC-RICH PRIMER (69/90500) Epoxy zinc-rich powder coating primer. Part of a two-coat TIGER Shield system. Designed to impart superior corrosion protection to steel

More information

Implants of high-performance ceramic. vk-lange 12.03.2007 14:44 Uhr Seite 1. One-piece precision implant. Made in Germany

Implants of high-performance ceramic. vk-lange 12.03.2007 14:44 Uhr Seite 1. One-piece precision implant. Made in Germany OMNIS Implants of high-performance ceramic vk-lange 12.03.2007 14:44 Uhr Seite 1 One-piece precision implant C M Y CM MY CY CMY K Dieter Lange Verkaufsleiter Labor Made in Germany creamed nge 12.03.2007

More information

EUROTUBO DELTALAB 6. SWABS

EUROTUBO DELTALAB 6. SWABS 92 93 94 The swab, sterile or non sterile, is used for biological sample collection. Specially used for processing samples which, after being coloured, will be analysed by microscopy. Also suitable for

More information

páêçå~=aéåí~ä=`^al`^j=póëíéã qá_~ëé

páêçå~=aéåí~ä=`^al`^j=póëíéã qá_~ëé kéï=~ë=çñw MSKOMNS páêçå~=aéåí~ä=`^al`^j=póëíéã qá_~ëé lééê~íáåö=fåëíêìåíáçåë båöäáëü=erpf Operating Instructions = Table of contents Sirona Dental Systems GmbH Table of contents 1 Symbols used... 3 2

More information

Erich Lacher Präzisionsteile

Erich Lacher Präzisionsteile Nexxus Industriewerbung 2893 12.13 Printed in Germany Erich Lacher Präzisionsteile GmbH & Co. KG Certified by Im Altgefäll 22 D 75181 Pforzheim Phone: +49 (0)7231/6097-0 Fax: +49 (0)7231/6097-60 E-Mail:

More information

SKY Titanium Implants

SKY Titanium Implants SKY Titanium Implants Easy & safe prosthetically versatile 3D osseo connect surface (ocs ) Depending on the implant s positioning, a corresponding coronal implant design is needed for optimally fulfilling

More information

SRT screw removal tool

SRT screw removal tool SRT screw removal tool As far as the SRT tool, the clinician will place the tip of it in the screw so it lines up into the screw hole opening. They will turn the tool slowly about ¼ of a turn clockwise,

More information

510(k) Summary. Atlanti STM Abutment and AtlantisTM Crown Abutment in Zirconia for Dentsply Ankylos Implant

510(k) Summary. Atlanti STM Abutment and AtlantisTM Crown Abutment in Zirconia for Dentsply Ankylos Implant /p(so 3 Premarket Notification SectionS5: Page - 4 JUL 5 2012 510(k) Summary Astra Tech Inc. Atlantisim Abutment and Atlantis~m Crown Abutment in Zirconia for Dentsply Ankylos Implant ADMINISTRATIVE INFORMATION

More information

Reconciliation, Inspection and Checks

Reconciliation, Inspection and Checks Chapter 15 Reconciliation, Inspection and Checks By the end of this chapter, you will be able to: l Explain the terms reconciliation, inspection, checks l Understand the importance of safe checking systems

More information

Surface Treatment of Titanium

Surface Treatment of Titanium Surface Treatment of Titanium Christiane Jung KKS Ultraschall AG, Steinen SZ The Tribology of Precision Swiss Tribology Meeting SBB Centre Löwenberg in Murten, Switzerland 16. November 2007 1 Outline:

More information

Content. 01 Introduction p 3

Content. 01 Introduction p 3 Biological Safety Testing of Cosmetics Content 01 Introduction p 3 02 Biocompatibility p 5 Cytotoxicity p 5 Genotoxicity p 5 Skin Corrosion p 6 Skin Irritation p 6 Skin Sensitization p 7 Eye Irritation

More information

Examination of failed landing gear struts MD Helicopters, Model MD520N VH-MPI 21 June 2004

Examination of failed landing gear struts MD Helicopters, Model MD520N VH-MPI 21 June 2004 Appendix A: Technical Analysis Report Examination of failed landing gear struts MD Helicopters, Model MD520N VH-MPI 21 June 2004 Report No. 35/04 Task No. BE/200400015 Occurrence No. BO/200402243 Page

More information

Annex of the certificate (Page 1/2) Accreditation Scope

Annex of the certificate (Page 1/2) Accreditation Scope Annex of the certificate (Page 1/2) ISO 9001:2008 Quality Management System Certification Plaza Yukarı Dudullu * EA Code Description 1 Agriculture, forestry and fishing 2 Mining and quarrying 3 Food products,beverages

More information

TEPZZ 69 _ZA T EP 2 692 310 A2 (19) (11) EP 2 692 310 A2. (12) EUROPEAN PATENT APPLICATION published in accordance with Art.

TEPZZ 69 _ZA T EP 2 692 310 A2 (19) (11) EP 2 692 310 A2. (12) EUROPEAN PATENT APPLICATION published in accordance with Art. (19) TEPZZ 69 _ZA T (11) EP 2 692 3 A2 (12) EUROPEAN PATENT APPLICATION published in accordance with Art. 13(4) EPC (43) Date of publication: 0.02.14 Bulletin 14/06 (21) Application number: 1276632.0 (22)

More information

MatrixNEURO CMF Matrix

MatrixNEURO CMF Matrix MatrixNEURO CMF Matrix This publication is not intended for distribution in the USA. MatrixNEURO Introduction The aim of surgical fracture treatment is to reconstruct the bony anatomy and restore its function.

More information

Grooved gaskets. Types of gaskets

Grooved gaskets. Types of gaskets Types of gaskets have proven extremely useful in all areas of industry, including the most demanding sealing tasks. Our grooved gaskets can be found in conventional power plants as well as in the primary

More information

INDUSTRIAL THERMOMETERS

INDUSTRIAL THERMOMETERS JJ SIKA thermometers for industry and marine sector JJ Special versions and accessories JJ SIKA thermometers for heating, air conditioning and ventilation (HVAC) INDUSTRIAL THERMOMETERS Contains products

More information

Metal Injection Molding (MIM) of components made of Titanium and its alloys

Metal Injection Molding (MIM) of components made of Titanium and its alloys Metal Injection Molding (MIM) of components made of Titanium and its alloys 1 Presentation content Introduction to Metal Injection Molding (MIM) Technology - explaination Products - examples Company brief

More information

European Technical Assessment ETA-10/0153 of 10/06/2015

European Technical Assessment ETA-10/0153 of 10/06/2015 ETA-Danmark A/S Göteborg Plads 1 DK-2150 Nordhavn Tel. +45 72 24 59 00 Fax +45 72 24 59 04 Internet ww.etadanmark.dk Authorised and notified according to Article 29 of the Regulation (EU) No 305/2011 of

More information

Sterile Cleanroom Management

Sterile Cleanroom Management Sterile Cleanroom Management Lynn Stanard, Sr. Quality Manager, Berkshire Corporation When manufacturing in an aseptic environment, it is critical to ensure that the various cleanroom consumables, such

More information

BUMAX. REYHER your partner for the BUMAX range

BUMAX. REYHER your partner for the BUMAX range BUMAX high-tensile stainless steel fasteners REYHER your partner for the BUMAX range Strongest stainless steel fasteners in the world BUMAX 88 and BUMAX ready for delivery from stock Wide range of BUMAX

More information

Negative graduations for extra capacity Lot number for complete traceability

Negative graduations for extra capacity Lot number for complete traceability Pipettes 37 Pipettes, Serological Sterilin single use, serological pipettes are manufactured using virgin grade polystyrene and to stringent quality specifications. All pipettes in our extensive range

More information

JIS G3472 Electric Resistance Welded Carbon Steel Tubes for Automobile Structural Purposes

JIS G3472 Electric Resistance Welded Carbon Steel Tubes for Automobile Structural Purposes JIS G3472 Electric Resistance Welded Carbon Steel Tubes for Automobile Structural Purposes 1. Scope This Japanese Industrial Standard specifies the electric resistance welded carbon steel tubes, hereinafter

More information

Legacy3 System Overview Catalog. alog. 3.2mmD 3.7mmD 4.2mmD. Legacy 3. 4.7mmD 5.2mmD 5.7mmD

Legacy3 System Overview Catalog. alog. 3.2mmD 3.7mmD 4.2mmD. Legacy 3. 4.7mmD 5.2mmD 5.7mmD Legacy3 System Overview Catalog alog 3.2mmD 3.7mmD 4.2mmD Legacy 3 4.7mmD 5.2mmD 5.7mmD Legacy3 Legacy3 Two-Stage System Featuring: Internal connection with 1.4mm long hex and internal lead-in bevel Tapered

More information

Decoding Heat Cure Denture Base Polymers. By Tom Zaleske

Decoding Heat Cure Denture Base Polymers. By Tom Zaleske Decoding Heat Cure Denture Base Polymers By Tom Zaleske 24 Journal of Dental Technology August/September 2007 s dental technicians and laboratory owners trying to survive in a global marketplace, we often

More information

Outline of a quality system and standard for the certification of conformity

Outline of a quality system and standard for the certification of conformity Outline of a quality system and standard for the certification of conformity Although still in early steps, novel Additive Manufacturing (AM) processes are growing in expectations as enabling technology

More information

Optimet 3D Dental Multi-Facet Scanner Attainable Accuracy for Dental Application Cases

Optimet 3D Dental Multi-Facet Scanner Attainable Accuracy for Dental Application Cases Optimet 3D Dental Multi-Facet Scanner Attainable Accuracy for Dental Application Cases Optimet Dental 3D Scanner This paper presents an overview of the Optimet multi-facet Dental Scanner used for 3D scanning

More information

HOME OFFICE SPECIFICATION FOR SEAMLESS ALLOY STEEL CYLINDERS FOR THE CONVEYANCE OF COMPRESSED GASES HOT

HOME OFFICE SPECIFICATION FOR SEAMLESS ALLOY STEEL CYLINDERS FOR THE CONVEYANCE OF COMPRESSED GASES HOT HOME OFFICE SPECIFICATION FOR SEAMLESS ALLOY STEEL CYLINDERS FOR THE CONVEYANCE OF COMPRESSED GASES HOT 1 Cylinders manufactured to these specifications shall be manufactured by a cylinder manufacturer

More information

Dental Radiography collimator Ionising radiation image radiolucent area radiopaque area controlled zone scatter radiation intraoral

Dental Radiography collimator Ionising radiation image radiolucent area radiopaque area controlled zone scatter radiation intraoral Dental Radiography X-rays for dental radiography are produced by high voltages of electricity within an x-ray head and come out through a metal tube called a collimator. This ensures the x-rays only come

More information

r5 73~ 9/ / 510(K) Summary 13. 510(K) SUMMARY

r5 73~ 9/ / 510(K) Summary 13. 510(K) SUMMARY r5 73~ 9/ / 13. 510(K) SUMMARY Mega'Gen Co, Ltd JAN 1 0 2006 114-8 Eupchun-Ri Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: 82-53-857-5770, Fax: 82-53-857-5432 510(K) Summary 510(K) SUMMARY AND CERTIFICATION

More information

Stryker Hand Plating System

Stryker Hand Plating System Stryker Hand Plating System Operative Technique VariAx Hand Locking Plate Module Profyle Hand Standard Plating Module Stryker Hand Plating System The Stryker Hand Plating System was developed with one

More information

Quick guide: using CTE security straws for cryopreservation of pronuclear stages, embryos and sperm

Quick guide: using CTE security straws for cryopreservation of pronuclear stages, embryos and sperm Quick guide: using CTE security straws for cryopreservation of pronuclear stages, embryos and sperm 1. How to prepare straws for pronuclear stages and embryos (use straws with plug, 66.5 mm) Straws are

More information

Thread and End Connection

Thread and End Connection www.swagelok.com and End Connection Identification Guide 2 Contents Introduction and End Connection Terminology.. 4 General Terminology... 5 Step-by-Step Identification Procedure for s and End Connections...

More information

EUROTUBO DELTALAB 4. PETRI DISHES AND LOOPS

EUROTUBO DELTALAB 4. PETRI DISHES AND LOOPS 77 78 90 x 14 mm Petri Dish Made in polystyrene. Vented. Supplied in groups of 20 units, packaged in heat sealed bags. Code 200200 is ASEPTIC. Code 200209 is sterile by gamma radiation. Suitable for automatic

More information

ASSEMBLY, INSTALLATION, AND REMOVAL OF CONTACTS AND MODULES

ASSEMBLY, INSTALLATION, AND REMOVAL OF CONTACTS AND MODULES ASSEMBLY, INSTALLATION, AND REMOVAL OF CONTACTS AND MODULES FOR FIBER OPTIC CONTACTS AND MODULES Table of Contents SECTION 1 CONTACT INSTALLATION AND REMOVAL SECTION 2 MODULE INSTALLATION AND REMOVAL SECTION

More information

The UNFOLDER Silver Series Implantation System

The UNFOLDER Silver Series Implantation System The UNFOLDER Silver Series Implantation System Z310845 Rev. D EN Revision Date: 02/2012 Description The UNFOLDER Silver Series Implantation System consists of the following components: The UNFOLDER Silver

More information

ABUTMENT/ LOADING MEMBER, CONNECTION SCREW AND DENTAL IMPLANT SYSTEM WITH INTERNAL MORSE TAPER CONNECTION. RESULTS OF STATIC RESISTANCE

ABUTMENT/ LOADING MEMBER, CONNECTION SCREW AND DENTAL IMPLANT SYSTEM WITH INTERNAL MORSE TAPER CONNECTION. RESULTS OF STATIC RESISTANCE ABUTMENT/ LOADING MEMBER, CONNECTION SCREW AND DENTAL IMPLANT SYSTEM WITH INTERNAL MORSE TAPER CONNECTION. RESULTS OF STATIC RESISTANCE TO COMPRESSION BENDING On request of: Medical Precision Implants,

More information

Straumann Dental Implant System. Implant Selection Guide.

Straumann Dental Implant System. Implant Selection Guide. Straumann Dental Implant System. Implant Selection Guide. STRAUMANN's IMPLANT PORTFOLIO The Straumann Dental Implant System offers two implant lines with diverse body and neck designs ranging from the

More information

NEW SIX-SEALS CUTTING RING. INTERNATIONAL INDUSTRIAL PATENT Nr. 864061 of the 10/03/99 FLANKS AND DOES NOT REPLACE THE STANDARD RING CURRENTLY IN USE

NEW SIX-SEALS CUTTING RING. INTERNATIONAL INDUSTRIAL PATENT Nr. 864061 of the 10/03/99 FLANKS AND DOES NOT REPLACE THE STANDARD RING CURRENTLY IN USE B4 NEW SIX-SEALS CUTTING RING. INTERNATIONAL INDUSTRIAL PATENT Nr. 864061 of the 10/03/99 FLANKS AND DOES NOT REPLACE THE STANDARD RING CURRENTLY IN USE AVAILABLE IN CARBON AND STAINLESS STEEL 23 THEORY

More information

ALL-CERAMIC DENTAL IMPLANT SOLUTIONS

ALL-CERAMIC DENTAL IMPLANT SOLUTIONS ALL-CERAMIC DENTAL IMPLANT SOLUTIONS Scientific Evidence Bone-to-implant contact of 78% at 3 months. One piece implant = no prosthetic connections References 1. One-year follow-up of first consecutive

More information

HUS-V Screw anchor. HUS-V Screw anchor. Basic loading data (for a single anchor) Mean ultimate resistance

HUS-V Screw anchor. HUS-V Screw anchor. Basic loading data (for a single anchor) Mean ultimate resistance HUS-V Screw anchor Anchor version HUS-V 8 / 10 Carbon steel concrete screw with hexagonal head Benefits - High productivity less drilling and fewer operations than with conventional anchors - Technical

More information

Bego Implant Systems. Special edition 2014/2015. Partners in Progress

Bego Implant Systems. Special edition 2014/2015. Partners in Progress Bego Implant Systems Platform Switch Prosthetics Special edition 2014/2015 Partners in Progress The PS-Line abutments which have been ideally adapted for the Platform Switch of the BEGO Semados RS/RSX

More information

High-Quality Gx Glass Tubing for Pharmaceutical Packaging

High-Quality Gx Glass Tubing for Pharmaceutical Packaging High-Quality Gx Glass Tubing for Pharmaceutical Packaging www.gerresheimer.com Glass Tubing for Pharmaceutical Packaging Gerresheimer Tubing and Converting Products Tubing Converting Pisa Italy Vineland

More information

Gl GinGival level implant

Gl GinGival level implant GL Gingival Level implant TABLE OF CONTENTS GL - Gingival Level implant Implant characteristics page 04 Dental implant page 05 Prosthetic components page 06 Ball attachment system page 08 Temporary peek

More information

SCHMIDT ManualPress 300 Series Manual Presses with Process Monitoring

SCHMIDT ManualPress 300 Series Manual Presses with Process Monitoring Manual Presses with Process Monitoring Process reliability, force/stroke monitoring of the joining process and EN ISO- compatible documentation of the results are becoming the major factors for small and

More information

New in the PFERD Product Line 204

New in the PFERD Product Line 204 COMBICLICK Fibre Discs COMBICLICK fibre discs Silicon carbide SiC D The silicon carbide SiC type is suitable for working on aluminium, copper, bronze, titanium, high-alloy steels and fibre reinforced plastics.

More information

ExpertEase Surgery Step-by-Step. new. Surgery

ExpertEase Surgery Step-by-Step. new. Surgery ExpertEase Surgery Step-by-Step new Surgery ExpertEase computer-guided planning and surgical guides In the first stage the future denture is designed with reference to esthetic, functional and phonetic

More information

DRIED VEGETABLES. Food and Agriculture Organization of the United Nations

DRIED VEGETABLES. Food and Agriculture Organization of the United Nations DRIED VEGETABLES Food and Agriculture Organization of the United Nations DRIED VEGETABLES 1.- Dried Vegetable Processing - General Information The vegetable dehydration technique is reasonably simple and

More information

From UV To IR Precision Across The Spectrum STANDARD MICROSTRUCTURES

From UV To IR Precision Across The Spectrum STANDARD MICROSTRUCTURES From UV To IR Precision Across The Spectrum STANDARD MICROSTRUCTURES STANDARD MICROSTRUCTURES SPECIFICATIONS OUR STANDARD PRODUCTS The graticules shown here are offered as standard products for sale as

More information

Cleanroom Packaging Protect against contamination

Cleanroom Packaging Protect against contamination Cleanroom Packaging Protect against contamination Dr. Christoph Strubl STRUBL GmbH & Co. KG Kunststoffverpackungen STRUBL GmbH & Co. KG Kunststoffverpackungen, Richtweg 52, D 90530 Wendelstein Tel:+49(0)9129-9035

More information

Scuffing Measurement Methodology and Improved Film Coating Systems

Scuffing Measurement Methodology and Improved Film Coating Systems OPADRY II Application Data High Performance Film Coating System Scuffing Measurement Methodology and Improved Film Coating Systems PURPOSE Scuffing is a term used to describe coated tablet defects consisting

More information

IMPLANT CONSENT FORM WHAT ARE DENTAL IMPLANTS?

IMPLANT CONSENT FORM WHAT ARE DENTAL IMPLANTS? IMPLANT CONSENT FORM WHAT ARE DENTAL IMPLANTS? Dental implants are a very successful and accepted treatment option to replace lost or missing teeth. A dental implant is essentially an artificial tooth

More information

Discover the new ANKYLOS generation: ANKYLOS C/X with the option of indexing & more...

Discover the new ANKYLOS generation: ANKYLOS C/X with the option of indexing & more... Discover the new ANKYLOS generation: ANKYLOS C/X with the option of indexing & more... New horizons exciting outlook For more than 20 years ANKYLOS with its unique, friction-locked and keyed TissueCare

More information

GINGIVAL LEVEL implant

GINGIVAL LEVEL implant GL GINGIVAL LEVEL implant English version TABLE OF CONTENTS GL - GINGIVAL LEVEL IMPLANT Implant characteristics page 04 Dental implant page 05 Prosthetic components page 06 Ball attachment system page

More information

Classification of dental cements

Classification of dental cements Classification of dental cements Type I: Luting agents* that include temporary cements Class 1: powder-liquid -> harden Class 2: paste-paste -> remain soft Type II: Luting agents for permanent applications

More information

Straumann Dental ONE SYSTEM ONE INSTRUMENT KIT VARIOUS TREATMENTS

Straumann Dental ONE SYSTEM ONE INSTRUMENT KIT VARIOUS TREATMENTS Straumann Dental implant system ONE SYSTEM ONE INSTRUMENT KIT VARIOUS TREATMENTS For various treatments* The Straumann Dental Implant System offers you and your patients efficient and esthetic implant-borne

More information

UNLIMITED VARIETY OF CREATIVE SHEET MATERIAL.

UNLIMITED VARIETY OF CREATIVE SHEET MATERIAL. UNLIMITED VARIETY OF CREATIVE SHEET MATERIAL. MADE IN SWITZERLAND Airex AG was founded in 1956 and pioneers with its innovations in the field of foamed plastic materials. Apart from manufacturing technical

More information

RESTORING STRAUMANN IMPLANTS WITH LOCATOR ABUTMENTS

RESTORING STRAUMANN IMPLANTS WITH LOCATOR ABUTMENTS RESTORING STRAUMANN IMPLANTS WITH LOCATOR ABUTMENTS Straumann is the industrial partner of the ITI (International Team for Implantology) in the areas of research, development, and education. CONTENTS Product

More information

- ISO Pneumatic Cylinder

- ISO Pneumatic Cylinder Installation, Operation and Maintenance January 2000 - Series P1E (Lightweight Aluminum Design) 32 mm through 100 mm Index Introduction... 1 Technical Specifications... 1 Constructive Specifications...

More information

chronos BOne VOid Filler Beta-Tricalcium Phosphate (b-tcp) bone graft substitute

chronos BOne VOid Filler Beta-Tricalcium Phosphate (b-tcp) bone graft substitute chronos BOne VOid Filler Beta-Tricalcium Phosphate (b-tcp) bone graft substitute chronos Bone Void Filler Osteoconductive Resorbable Synthetic chronos Granules and Preforms are synthetic, porous, osteoconductive,

More information

Packaging Validation according to ISO 11607

Packaging Validation according to ISO 11607 Synergy makes sence Packaging Validation according to ISO 11607 MG-FSI72-104 Last revision: March 2011 5, Chemin du Catupolan - 69120 Vaulx en Velin - France - Tel. 33 (0)4 72 81 22 62 - Fax : 33 (0)4

More information

ball abutment overdenture: chairside pick-up using existing denture

ball abutment overdenture: chairside pick-up using existing denture ball abutment overdenture: chairside pick-up using existing denture This prosthetic technique module may contain references to the complete Prosthetic Manual (L02015). To download the full Prosthetic Manual,

More information

BCP SURFACE TREATMENT. Pure like nature

BCP SURFACE TREATMENT. Pure like nature B i o c o m p a t i b i l i t y. C l e a n l i n e s s. O s s e o i n t e g r a t i o n BCP SURFACE TREATMENT Pure like nature 2 THE CORNERSTONE OF A SUCCESSFUL DENTAL Promoting fast and effective osseointegration

More information

TECHNICAL DATA SHEET GRILON BG-15 S

TECHNICAL DATA SHEET GRILON BG-15 S TECHNICAL DATA SHEET GRILON BG-1 S Grilon BG-1 S is a heat stabilised PA6 injection moulding grade with 1% glass fibres. Grilon BG-1 S has the following important properties: Excellent surface finish Easy

More information

Laboratory. Regular C/X Laboratory Technique

Laboratory. Regular C/X Laboratory Technique Some products may not be available in all countries. Please contact your DENTSPLY Friadent representative to obtain up to date information on the product range and on availability. Laboratory Order no.

More information

Straumann Dental Implant System. Fax Order Form Collection.*

Straumann Dental Implant System. Fax Order Form Collection.* Straumann Dental Implant System. Fax Order Form Collection.* * The NNC Fax Order Form is still a stand alone document due to the unique restorative portfolio Straumann Roxolid SLActive Tissue Level Implants

More information

Screw Cap Micro Tubes

Screw Cap Micro Tubes Screw Cap Micro Tubes For transport, storage and sample preparation Reliable quality and versatility Sicherheit Uncompromising... quality and purity Sicherheit... Over 30 years ago, Sarstedt introduced

More information

APPEARANCE GRADES NOVEMBER 2012

APPEARANCE GRADES NOVEMBER 2012 APPEARANCE GRADES NOVEMBER 2012 This document contains information on the primary grades of appearance timber. Appearance grades of timber, rough or surfaced two faces, shall unless otherwise specified,

More information

Lecture 5 Different types of microscopes: UV, dark field, phase contrast, fluorescence and electron microscope.

Lecture 5 Different types of microscopes: UV, dark field, phase contrast, fluorescence and electron microscope. Lecture 5 Different types of microscopes: UV, dark field, phase contrast, fluorescence and electron microscope. Learning objectives: In continuation last class on the principles and basic types of microscopes,

More information

The College of Dental Surgeons of Hong Kong. Guidelines for the Provision of Dental Implants

The College of Dental Surgeons of Hong Kong. Guidelines for the Provision of Dental Implants Final (20101018) The College of Dental Surgeons of Hong Kong Guidelines for the Provision of Dental Implants 1. Introduction Restorations supported by dental implants have become an accepted method for

More information

OFFICE OF PERSONNEL MANAGEMENT MERIT SYSTEMS OVERSIGHT AND EFFECTIVENESS DALLAS OVERSIGHT DIVISION CLASSIFICATION APPEAL DECISION

OFFICE OF PERSONNEL MANAGEMENT MERIT SYSTEMS OVERSIGHT AND EFFECTIVENESS DALLAS OVERSIGHT DIVISION CLASSIFICATION APPEAL DECISION OFFICE OF PERSONNEL MANAGEMENT MERIT SYSTEMS OVERSIGHT AND EFFECTIVENESS DALLAS OVERSIGHT DIVISION CLASSIFICATION APPEAL DECISION Under section 5112(b) of title 5, United States Code Appellant: Position:

More information

Luigi Vito Stefanelli,D.Eng.,DDS

Luigi Vito Stefanelli,D.Eng.,DDS LYON, 27-28/09/2013 Luigi Vito Stefanelli,D.Eng.,DDS Assistant Researcher, Department of Oral Sciences, Sapienza University of Rome, Italy, School of Dentistry. Private practitioner dental office Stasi

More information

PERIOTEST. high-quality dentistry

PERIOTEST. high-quality dentistry PERIOTEST dental measuring instrument for implantology and high-quality dentistry ABOUT MEDIZINTECHNIK GULDEN In 1997, Medizintechnik Gulden acquired from Siemens AG exclusive rights for the manufacture

More information

2.3. The management in each HCF shall be responsible for ensuring good waste management practices in their premises.

2.3. The management in each HCF shall be responsible for ensuring good waste management practices in their premises. 1. PURPOSE Health-care activities lead to production of medical waste that may lead to adverse health effects. Most of this waste is not more dangerous than regular household waste. However, some types

More information

TABLE OF CONTENTS. Surgical Technique 2. Indications 4. Product Information 5. 1. Patient Positioning and Approach 2

TABLE OF CONTENTS. Surgical Technique 2. Indications 4. Product Information 5. 1. Patient Positioning and Approach 2 Surgical Technique TABLE OF CONTENTS Surgical Technique 2 1. Patient Positioning and Approach 2 2. Intervertebral Device Implanted 2 3. Buttress Plate Selection 2 4. Awl Insertion 2 5. Screw Insertion

More information

DENTAL IMPLANTS. Consider the implant alternative

DENTAL IMPLANTS. Consider the implant alternative DENTAL IMPLANTS Consider the implant alternative WHAT IS A DENTAL IMPLANT? A dental implant is typically a small screw shaped attachment usually made from titanium. It is inserted within the jawbone to

More information

Important Notes Color

Important Notes Color Important Notes Color Introduction A definition for color (MPI Glossary) The selective reflection of light waves in the visible spectrum. Materials that show specific absorption of light will appear the

More information

Hot Rolled Square Steel Bars

Hot Rolled Square Steel Bars Page 1 of 16 Viale Certosa, 249-20151 Milano Tel: +39 02 30 700 - Fax: +39 02 38000 346 - Mail: commerciale.riva@rivagroup.com Production Units: Cerveno (BS), Italy Page 2 of 16 Products STRUCTURAL AND

More information