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Bifix QM
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1217510(k) K060894Ref 1759
by VOCO GmbH
Identity
- Trade Name
- Bifix QM EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Bifix QM EUDAMEDDual-curing universal composite-based luting system. FDA UDIDual-curing universal composite-based luting system. For all materials (metal, composite inlays and ceramic, also zirconium dioxide). Bubble-free perfect mixing. Direct application. Excellent adhesion to dentine, enamel and to metals. Special one-step Ceramic bond for optimal adhesion to porcelain. Radiopaque. Available in three shadese. Try-In pastes simplify shade selection before cementation. All-in-one set. FDA UDI
- Model / Reference
- 1217 EUDAMEDFDA UDI1759 EUDAMEDFDA UDI
- Description
- Dual-curing universal composite-based luting system. FDA UDIDual-curing universal composite-based luting system. For all materials (metal, composite inlays and ceramic, also zirconium dioxide). Bubble-free perfect mixing. Direct application. Excellent adhesion to dentine, enamel and to metals. Special one-step Ceramic bond for optimal adhesion to porcelain. Radiopaque. Available in three shadese. Try-In pastes simplify shade selection before cementation. All-in-one set. FDA UDI
Identifiers
- Catalog Number
- 1759 FDA UDI1217 FDA UDI
- Primary DI / UDI-DI
- E22112171 EUDAMEDFDA UDIE22117591 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210235000000000BR EUDAMED
- FDA Product Code
- EMA 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
- 872.3275 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
Bifix QM 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 | K060894 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210235000000000BR | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (5)
- EUDAMED 639fabd1-8351-46b1-a662-be0c3a442ae6 85 fields · synced Jul 17, 2026
- FDA UDI b145c204-2d81-4ded-b25f-602ff6e9dd9e 36 fields · synced May 27, 2026
- FDA UDI 06f0eea2-4f8a-4599-8626-0efca895b6a3 36 fields · synced May 30, 2026
- EUDAMED b20d6017-336b-439f-8410-574963db491a 61 fields · synced Jul 17, 2026
- FDA 510(k) K060894 1 fields · synced May 18, 2026