Cleared Traditional

tmCMF Solution

K231520 · Techmah Cmf · Dental
Oct 2023
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K231520 is an FDA 510(k) clearance for the tmCMF Solution, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by Techmah Cmf (Knoxville, US). The FDA issued a Cleared decision on October 2, 2023, 130 days after receiving the submission on May 25, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K231520 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2023
Decision Date October 02, 2023
Days to Decision 130 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZJ — Driver, Wire, And Bone Drill, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120