Cleared Traditional

turbodent touch

K251425 · Mectron S.P.A. · Dental
May 2025
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K251425 is an FDA 510(k) clearance for the turbodent touch, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on May 9, 2025, 1 days after receiving the submission on May 8, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K251425 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2025
Decision Date May 09, 2025
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KOJ — Airbrush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6080