FDA cleared the Profisil Free from Kettenbach GmbH & Co. KG on Sep 3, 2026 under K262243, a traditional 510(k). The device falls under product code LBH, Varnish, Cavity, regulated at 21 CFR 872.3260 as a Class 2 device. The review panel was Dental.
FDA logged the submission as received on Jul 1, 2026. The decision came 64 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for Kettenbach GmbH & Co. KG in the last 12 months of the tracker.
K262243 is the FDA 510(k) for Profisil Free, submitted by Kettenbach GmbH & Co. KG. FDA's decision date was Sep 3, 2026, under product code LBH (Varnish, Cavity).
Kettenbach GmbH & Co. KG, based in Eschenburg, is the applicant of record for K262243.
FDA received the submission on Jul 1, 2026 and issued its decision on Sep 3, 2026, 64 days later.
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