Cleared Traditional

MTA vpt

K251390 · Voco GmbH · Dental
Jul 2025
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K251390 is an FDA 510(k) clearance for the MTA vpt, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on July 3, 2025, 59 days after receiving the submission on May 5, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K251390 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2025
Decision Date July 03, 2025
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820