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Tetric N-Ceram Refill 10x0.25g B2 Dentin
EUDAMEDClass IIa (EU MDR)
Ref 616871AN
Identity
- Trade Name
- Tetric N-Ceram Refill 10x0.25g B2 Dentin EUDAMED
- Device Name
- Tetric EvoCeram, Tetric N-Ceram, Tetric N-Ceram 2, Tetric Prime, Tetric 100 Universal, Tetric 100 Univ 2, Evetric, Te-Econom Plus, Tetric plus Fill, Choice Fill, Choice N-Fill, Tetric N-plus Fill, Tetric plus 100 Fill EUDAMED
- Model / Reference
- 616871AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07615208298550 EUDAMED
- Basic UDI-DI
- 76152082AFILL004JG EUDAMED
- Unit of Use DI
- 07615208468670 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Liechtenstein EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental composite resin
Tetric N-Ceram Refill 10x0.25g B2 Dentin by Ivoclar Vivadent AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76152082AFILL004JG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (1)
- EUDAMED 18dacecc-20f2-4a40-a4ee-b07a91c887b4 61 fields · synced Oct 7, 2026