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Admira Fusion x-tra
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2810510(k) K151956Ref 2811
by VOCO GmbH
Identity
- Trade Name
- Admira Fusion x-tra EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Admira Fusion x-tra EUDAMEDNanohybrid ORMOCER restorative material, 4mm. FDA UDI
- Model / Reference
- 2810 EUDAMEDFDA UDI2811 EUDAMEDFDA UDI
- Description
- Nanohybrid ORMOCER restorative material, 4mm. FDA UDI
Identifiers
- Catalog Number
- 2810 FDA UDI2811 FDA UDI
- Primary DI / UDI-DI
- E22128101 EUDAMEDFDA UDIE22128111 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210086000000000F7 EUDAMED
- 510(k) Number
- K151956 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
Admira Fusion x-tra by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K151956 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210086000000000F7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (5)
- EUDAMED d4244482-075d-4806-953e-12465f98fb07 85 fields · synced Jul 12, 2026
- FDA UDI 6ca05ac0-c8e3-4783-90a5-47164e36f660 37 fields · synced May 30, 2026
- FDA UDI 783954d5-cb7d-466d-9e75-7c4899bb1f09 37 fields · synced May 30, 2026
- EUDAMED 79789d67-28d0-4e8e-9f24-16bd29175e43 61 fields · synced Jul 12, 2026
- FDA 510(k) K151956 1 fields · synced May 18, 2026