Cleared Traditional

tmCMF Solution

K233874 · Techmah Cmf · Dental
Jul 2024
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K233874 is an FDA 510(k) clearance for the tmCMF Solution, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Techmah Cmf (Knoxville, US). The FDA issued a Cleared decision on July 11, 2024, 217 days after receiving the submission on December 7, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K233874 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2023
Decision Date July 11, 2024
Days to Decision 217 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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