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Admira Fusion x-base
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2812510(k) K170896
by VOCO GmbH
Identity
- Trade Name
- Admira Fusion x-base FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Admira Fusion x-base EUDAMED
- Model / Reference
- 2812 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2812 FDA UDI
- Primary DI / UDI-DI
- E22128121 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210088000000000GZ EUDAMED
- 510(k) Number
- K170896 FDA UDI
- 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
- Germany 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
No
FDA UDI
Category: Dental composite resin
Admira Fusion x-base by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170896 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210088000000000GZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (3)
- EUDAMED ced3e64f-94fb-4a8f-893b-35e2c4b9e332 85 fields · synced Jun 19, 2026
- FDA UDI a1015612-9811-4ad7-a52e-1672e3344f62 36 fields · synced May 29, 2026
- FDA 510(k) K170896 1 fields · synced May 18, 2026