Bifix Hybrid Abutment Cement
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identity
- Trade Name
- Bifix Hybrid Abutment EUDAMED
- Device Name
- Bifix Hybrid Abutment EUDAMED
- Model / Reference
- syringe EUDAMED2414 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E22124141 EUDAMED
- Basic UDI-DI
- B-E22124141 EUDAMED
- 510(k) Number
- K220640 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Bifix Hybrid Abutment Cement is a dual-curing, self-adhesive composite-based adhesive system designed for dental applications. It functions as a bonding agent between dental abutments and restorations, ensuring a secure mechanical and chemical attachment to both tooth structure and prosthetic components.
This cement is supplied as a reusable, non-sterile material intended for intraoral and extraoral use in dental procedures. It is classified as a Class II medical device under FDA regulations and complies with the Medical Device Directive (MDD). The product is provided in specific packaging sizes, with no indication of MRI safety or single-use requirements in the provided data.
Frequently asked questions
Is the Bifix Hybrid Abutment Cement intended for single-use or can it be reused in multiple procedures?
The Bifix Hybrid Abutment Cement is explicitly described as a reusable material, meaning it can be used across multiple dental procedures. Since it is supplied in non-sterile packaging, it must be sterilized between uses according to standard dental protocols.
What types of dental procedures is this cement primarily used for, and how does it bond?
This cement is designed as a bonding agent between dental abutments and restorations, ensuring a secure mechanical and chemical attachment to both prosthetic components and tooth structures. It is specifically formulated for intraoral and extraoral use in procedures involving abutments, such as crowns, bridges, or implants.
How is the Bifix Hybrid Abutment Cement supplied, and what should I consider for storage?
The cement is supplied in specific packaging sizes but is non-sterile and reusable. Since it is not single-use, proper storage involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Sterilization protocols must be followed before reuse to ensure safety and efficacy.
Does this cement require any special handling or preparation before use?
As a dual-curing, self-adhesive composite-based adhesive, the Bifix Hybrid Abutment Cement is designed for ease of use but should be handled according to standard dental adhesive protocols. No additional preparation (like mixing) is mentioned, but proper surface cleaning of abutments and restorations is critical for optimal bonding. Always follow the manufacturer’s instructions for best results.
What regulatory pathways has this product followed, and how does that affect its use?
The Bifix Hybrid Abutment Cement has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD) in Europe. This means it has been evaluated for safety and effectiveness as a Class II medical device under FDA regulations. Clinicians should confirm local regulatory compliance before use, but no additional restrictions beyond standard dental adhesive practices are implied.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bifix SE - Befestigung | VOCO GmbH, Bifix Hybrid Abutment - Befestigung | VOCO GmbH, Bifix® QM Spritze universal (Voco) kaufen | minilu.de, Bifix® Veneer LC System Set (Voco) kaufen | minilu.de, Bifix SE - Nachfüllpackung - henryschein-dental.de
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220640 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA 510(k) K220640 24 fields · synced Oct 6, 2026
- EUDAMED cf5fa3a9-f61d-480e-9fad-147a11cdb0ae 61 fields · synced Jul 18, 2026