Cleared Traditional

K252606 - Bifix Veneer LC, Bifix Veneer Try-In (FDA 510(k) Clearance)

Mar 2026
Decision
214d
Days
Class 2
Risk

K252606 is an FDA 510(k) clearance for the Bifix Veneer LC, Bifix Veneer Try-In. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on March 20, 2026, 214 days after receiving the submission on August 18, 2025.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K252606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2025
Decision Date March 20, 2026
Days to Decision 214 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.3275