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1 CERTIFICATO CE DEL SISTEMA DI GARANZIA DELLA QUALITÀ EC Quality Assurance System Certificate Si certifica che, sulla base dei risultati degli audit effettuati, il Sistema completo di garanzia di Qualità dell Organizzazione: We certify that, on the basis of audit carried out, the full Quality Assurance System of the Organization: S.p.a Indirizzo/Address: Sede legale e operativa/ Registered and operational headquarter Via Veneto, Due Carrare - PD Italia È conforme ai requisiti applicabili della / Is in compliance with the applicable requirements of: Direttiva 93/42/CEE, Allegato II escluso il pto 4, attuata in Italia con Dlgs. 46 del 1997/02/24 93/42/EEC Directive, Annex II without point 4, transposed in Italy by Dlgs. 46 of 1997/02/24 per le seguenti tipologie di Dispositivi Medici / for the following Medical Devices: Laser ad uso odontoiatrico / Lasers for dentistry Micromotori per chirurgia ed endodonzia / Surgical and endodontic micromotors Impianti dentali / Dental implants Componentistica protesica dentale / Dental prosthetic components Strumenti chirurgici / Surgical instruments Kit chirurgici / Surgical kit Strumenti rotativi per odontoiatria / Rotary instruments for dentistry Cementi e materiali per otturazioni / Cements and materials for obturation Materiali per ricostruzione / Core build-up material Sistemi adesivi e mordenzanti / Bonding agents and etchants Resine composite per provvisori / Composite resins for temporaries Materiali per trattamento superficie dentale / Products for dental surface treatment Otturatori canalari / Endodontic Obturators Griglie in titanio per rigenerazione guidata / Titanium mesh for guided regeneration Dispositivi ortodontici / Orthodontic products Identificazione/Identification: Vedere allegato tecnico al presente Certificato/See technical sheet enclosed to this certificate Il presente Certificato è soggetto al rispetto del Regolamento KIWA CERMET ITALIA ed è valido solo per le tipologie di dispositivi sopra identificate soggette a sorveglianza. L allegato tecnico è parte integrante del presente Certificato. This Certificate is subject to KIWA CERMET ITALIA regulations and it is valid only for the above mentioned Medical Devices that are subject to survey.the technical sheet is an integrating part of this Certificate. Data di emissione/issue date: 2001/02/12 Data ultima modifica/last revised date: 2014/06/16 Data scadenza/ Expiry date: 2016/02/11 Pagina/Page: 1 di /of 7 Direttore Generale General Manager Giampiero Belcredi
2 S.p.a Laser ad uso odontoiatrico / Lasers for dentistry Light & Light Enjoy Enjoy5 Micromotori per chirurgia ed endodonzia / Surgical and endodontic micromotors E-Torque E-GO SPIN Heracle Impianti dentali / Dental implants Pro-Link Out-Link TG TG Shark Shelta Pagina/Page: 2 di /of 7
3 S.p.a Componentistica protesica dentale / Dental prosthetic components Pro-Link Out-Link TG TG Strumenti chirurgici / Surgical instruments Removal screw instruments Echo Plan Shorty Shelta Pagina/Page: 3 di /of 7
4 S.p.a Kit chirurgici / Surgical kit Sinus Lift M.I.S.E. Echo Plan Shorty Onebox Onebox2 Sinus Lift M.I.S.E. EVO Shelta Screw Kit Strumenti rotativi per odontoiatria / Rotative instruments for dentistry Frese in acciaio / Steel burs Frese in carburo di tungsteno / Carbide burs Frese diamantate / Diamond points Frese Domino / Domino burs Strumenti abrasivi / Abrasive points Gommini / Silicon rubbers Strumenti canalari M-TWO / Root canal instruments Frese chirurgiche /Surgical burs Mandrini /Mandrels Kit preparation drills Kit preparation drills for temporary bridges Pagina/Page: 4 di /of 7
5 S.p.a Cementi e materiali per otturazioni / Cements and materials for obturation Stone-implant, All Stone, Stone-AD, Stone-D, Stone-P, Stone-P free,stone-d Minimix Mtwo Gutta, Mtwo Apical Gutta Materiali per ricostruzione / Core build-up material Compositi per la ricostruzione dei monconi e la cementazione dei perni / Composite material for core build-up and root post cementation Virage Dual, Virage Plus Compositi per la ricostruzione / Universal composite for restorations AP, AP+, AP Flow, AP+ FLOW, ADONIS Perni endocanalari / Root posts Virage Post in fibra di vetro ed in fibra di carbonio / Virage Post glass fibre and carbon fibre MTWO POST in fibra di vetro ed in fibra di carbonio / MTWO Post glass fibre and carbon fibre MTWO KOR in fibra di vetro ed in fibra di carbonio / MTWO Kor glass fibre and carbon fibre Pagina/Page: 5 di /of 7
6 S.p.a Sistemi adesivi e mordenzanti / Bonding agents and etchants Link Link Primer Link Bonding Link Attivatore SURF-ETCH Resine composite per provvisori / Composite resins for temporaries Sun Materiali per trattamento superficie dentale / Products for dental surface treatment SNOW+ SNOW HOME SNOW 35 SNOW READY 25 SNOW HOME READY Otturatori canalari /Endodontic Obturators DOMINO Pagina/Page: 6 di /of 7
7 S.p.a Griglie in titanio per rigenerazione guidata / Titanium mesh for guided regeneration Griglie in titanio TINET FM / Titanium mesh TINET FM Dispositivi ortodontici / Orthodontic devices Attacchi ortodontici e tubi buccali /Brackets and buccal tubes GLICE CLICK GLARE GLARE Mini Archi ortodontici / Orthodontic archwires Legature metalliche (legature metalliche di varie forme,legature di Kobayashi)/Legature wires (ligature ties, Kobayashi ties) Tubi ortodontici (tubi a scorrere, sheats linguali) / Othodontic tubes (v-tubes, lingual sheats) Ganci ortodontici (ganci a palla, stop, ganci da estrusione, bottoni linguali, cleats linguali, capicorda, ganci chirurgici, uncini e archi chirurgici, uncini a T) / Orthodontic hooks (Ball clasps, crimpable stops, exhtrusion hooks, lingual buttons, lingual cleats, Lugs, shepherds hooks, Surgical&arch hooks, T-hooks) Molle ortodontiche / Orthodontic springs Elastomeri (elastici intra e extra orali, legature elastiche, catenelle elastomeriche, filo elastico, tubo protettivo per arco) Elastomers (Intraoral and extraoral elastics, Elastomeric ligature ties, Elastomeric chain elastic, Elastomeric thread, Elastomeric archwire protective sleeve) Accessori extraorali (Barre palatali, archi palatini,lip bumpers) / Orthodontic expanders (Palatal bars, Quad-Helix expander, Lip bumpers ) M.F. Extrusion Kit disposable instruments M.F. Extrusion Kit reusable instruments Pagina/Page: 7 di /of 7
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