Cleared Traditional

Combi Touch

K231391 · Mectron S.P.A. · Dental
May 2023
Decision
3d
Days
Class 2
Risk

About This 510(k) Submission

K231391 is an FDA 510(k) clearance for the Combi Touch, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on May 15, 2023, 3 days after receiving the submission on May 12, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K231391 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2023
Decision Date May 15, 2023
Days to Decision 3 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELC — Scaler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4850

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