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Tetric EvoCeram Refill 3x3g A3.5 Dentin
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 590304WW
Identity
- Trade Name
- Tetric EvoCeram Refill 3x3g A3.5 Dentin EUDAMEDTetric EvoCeram 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 EvoCeram Refill 3x3g A3.5 Dentin FDA UDI
- Model / Reference
- 590304WW EUDAMEDFDA UDI
- Description
- Tetric EvoCeram Refill 3x3g A3.5 Dentin FDA UDI
Identifiers
- Catalog Number
- 590304WW FDA UDI
- Primary DI / UDI-DI
- 07615208300536 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082AFILL004JG EUDAMED
- Unit of Use DI
- 07615208469165 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
No
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 EvoCeram Refill 3x3g A3.5 Dentin by Ivoclar Vivadent AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 f4ff61fc-bf0a-4e49-90c2-916616a6f24c 61 fields · synced Jun 19, 2026
- FDA UDI 24f8f457-6b71-4a55-bfb3-d928b61ceea6 34 fields · synced May 30, 2026