510(k) clearance

Profisil Free

FDA 510(k) source

510(k) number

K262243

Applicant

Kettenbach GmbH & Co. KG

Decision date

Sep 3, 2026

Date received

Jul 1, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LBH

Device type

Varnish, Cavity

Device class

Class II

Regulation

21 CFR 872.3260

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Eschenburg, DE