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. 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
- 1219 EUDAMEDFDA UDI
- Description
- Dual-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
- 1219 FDA UDI
- Primary DI / UDI-DI
- E22112191 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 II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA UDI fd18416b-3ac5-4ce6-83dd-0ef2c92c8844 36 fields · synced Oct 5, 2026
- EUDAMED 89714f46-1401-4823-8d60-e1ab7e19c42e 61 fields · synced Oct 5, 2026