Identity
- Trade Name
- Tetric Prime Refill 20x0.25g B1 EUDAMEDTetric Prime FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- 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 EUDAMEDTetric Prime Refill 20x0.25g B1 FDA UDI
- Model / Reference
- 706588US EUDAMEDFDA UDI
- Description
- Tetric Prime Refill 20x0.25g B1 FDA UDI
Identifiers
- Catalog Number
- 706588US FDA UDI
- Primary DI / UDI-DI
- 07615208292336 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082AFILL004JG EUDAMED
- Unit of Use DI
- 07615208467956 EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental composite resin
Tetric Prime Refill 20x0.25g B1 by Ivoclar Vivadent AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76152082AFILL004JG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (2)
- EUDAMED d7e90447-bcdd-4ecb-ac43-f9035493267e 61 fields · synced Jun 18, 2026
- FDA UDI 8ede6e02-2834-468e-9aa5-9c6096b615f3 34 fields · synced May 30, 2026