Cleared Traditional

VITA VMLC Primer

K251587 · Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · Dental

Feb 2026

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K251587 is an FDA 510(k) clearance for the VITA VMLC Primer, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (Baden-Wurttemberg, DE). The FDA issued a Cleared decision on February 23, 2026, 276 days after receiving the submission on May 23, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K251587 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2025
Decision Date	February 23, 2026
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF