Identity
- Trade Name
- Bifix SE FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Bifix SE EUDAMEDDual-curing self-adhesive composite-based luting system. FDA UDI
- Model / Reference
- 1784 EUDAMEDFDA UDI
- Description
- Dual-curing self-adhesive composite-based luting system. FDA UDI
Identifiers
- Catalog Number
- 1784 FDA UDI
- Primary DI / UDI-DI
- E22117841 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210237000000000DK EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010201 DENTAL BASE 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
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
Yes
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 SE by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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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 | K083438 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210237000000000DK | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (3)
- EUDAMED 6da7207b-79a1-42f3-830f-c42cc61f8ea1 61 fields · synced Jul 21, 2026
- FDA UDI 980a9d1a-205d-4b12-8d94-cbb0d549df22 36 fields · synced May 30, 2026
- FDA 510(k) K083438 1 fields · synced May 18, 2026