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Bifix Temp
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1055Ref 1056
by VOCO GmbH
Identity
- Trade Name
- Bifix Temp EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Bifix Temp EUDAMEDBifix Temp is a dual-curing, composite-based temporary luting material. FDA UDI
- Model / Reference
- 1055 EUDAMEDFDA UDI1056 EUDAMEDFDA UDI
- Description
- Bifix Temp is a dual-curing, composite-based temporary luting material. FDA UDI
Identifiers
- Catalog Number
- 1056 FDA UDI1055 FDA UDI
- Primary DI / UDI-DI
- E22110551 EUDAMEDFDA UDIE22110561 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210238000000000EG EUDAMED
- 510(k) Number
- K143212 FDA UDI
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS 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
No
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
Bifix Temp 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 | K143212 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210238000000000EG | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (5)
- EUDAMED df52ae12-fee6-474a-82ec-bf55a68df249 61 fields · synced Oct 6, 2026
- FDA UDI d6e648d0-8300-4ff3-bc78-6ea8688f0fe3 37 fields · synced May 29, 2026
- FDA UDI 5ac56369-3251-41f5-86b0-7bdf446f9b0e 37 fields · synced May 30, 2026
- EUDAMED 76c971b7-6fd6-4aa5-971e-9df62d28081d 61 fields · synced Jul 11, 2026
- FDA 510(k) K143212 1 fields · synced May 18, 2026