Identity
- Trade Name
- Bifix Hybrid Abutment Cement FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- 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). 10g QM syringe white HO FDA UDI
- Model / Reference
- 2412 FDA UDI
- 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). 10g QM syringe white HO FDA UDI
Identifiers
- Catalog Number
- 2412 FDA UDI
- Primary DI / UDI-DI
- E22124121 FDA UDI
- 510(k) Number
- K220640 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (1)
- FDA UDI f75d7d16-0d93-42b0-95d1-1a01ba476e9b 36 fields · synced Jun 6, 2026