Bifix Veneer LC, Bifix Veneer Try-In— 510(k) K252606
Substantially EquivalentVoco GmbH
FDA 510(k) clearance K252606 for Bifix Veneer LC, Bifix Veneer Try-In, Substantially Equivalent on 2026-03-20. Applicant: Voco GmbH. Device class: 2.
Summary
Voco's record covers Bifix Veneer LC and Bifix Veneer Try-In, filed under EMA, dental cements. The record doesn't list shades.
Class II, 21 CFR 872.3275. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
Voco filed from Cuxhaven, Germany. The decision came 214 calendar days after receipt (August 18, 2025 to March 20, 2026).
Clearance details
- Applicant
- Voco GmbH
- Product code
- Product code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cuxhaven, DE
Recent devices under product code EMA
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