tmCMF Solution

FDA 510(k) K233874 · Techmah Cmf

Substantially Equivalent

510(k) numberK233874

Submission

Device name
tmCMF Solution
Applicant
Techmah Cmf
Knoxville, TN, US
Received
December 7, 2023
Decision date
July 11, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JEY – Plate, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4760
Specialty
Dental
Implant
Yes

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Questions and answers

When was tmCMF Solution cleared by the FDA?

tmCMF Solution (K233874) received a 510(k) decision of Substantially Equivalent on July 11, 2024, 217 days after the submission was received.

What is the product code of K233874?

The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.