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Bifix Hybrid Abutment Cement
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 2410Model syringe
by VOCO GmbH
Identity
- Trade Name
- Bifx Hybrid Abutment EUDAMEDBifix Hybrid Abutment Cement FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Bifix Hybrid Abutment EUDAMEDBifix Hybrid Abutment Cement is a radiopaque, composite-based, dual-curing cementation system for the permanent cementation of abutment crowns and mesostructures made of metal, ceramics or polymers (composite or PMMA) on prefabricated adhesive/titanium bases (extraoral use), customized abutments made of titanium or zirconium dioxide or dental hard tissue (combination solutions). FDA UDI
- Model / Reference
- 2410 EUDAMEDFDA UDIsyringe EUDAMED
- Description
- Bifix Hybrid Abutment Cement is a radiopaque, composite-based, dual-curing cementation system for the permanent cementation of abutment crowns and mesostructures made of metal, ceramics or polymers (composite or PMMA) on prefabricated adhesive/titanium bases (extraoral use), customized abutments made of titanium or zirconium dioxide or dental hard tissue (combination solutions). FDA UDI
Identifiers
- Catalog Number
- 2410 FDA UDI
- Primary DI / UDI-DI
- E22124101 EUDAMEDFDA UDI
- Basic UDI-DI
- B-E22124101 EUDAMED
- 510(k) Number
- K220640 FDA UDI
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 Hybrid Abutment Cement by VOCO GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 278db269-d742-4e39-ac6f-517ff0faa268 36 fields · synced Jun 19, 2026
- EUDAMED 1ed347c5-a40d-4ea0-bf13-480aadb0628a 61 fields · synced Jun 19, 2026