510(k) K252606

Bifix Veneer LC, Bifix Veneer Try-In by Voco GmbH — Product Code EMA

K252606 is an FDA 510(k) premarket notification submitted by Voco GmbH for the device "Bifix Veneer LC, Bifix Veneer Try-In". The FDA issued a decision of Substantially Equivalent on March 20, 2026. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Voco GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2026
Date Received
August 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type