Cleared Traditional

MT-Bone

K242432 · Mectron S.P.A. · Dental
Aug 2024
Decision
3d
Days
Class 2
Risk

About This 510(k) Submission

K242432 is an FDA 510(k) clearance for the MT-Bone, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on August 19, 2024, 3 days after receiving the submission on August 16, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K242432 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2024
Decision Date August 19, 2024
Days to Decision 3 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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