# K262243: Profisil Free

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Sep 3, 2026 after 64 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K030922 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241489: ReminGel, Inter-Med, Inc. (2025) Summary page 6.

## Indications for use
Profisil® Free produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Source page: https://510kreport.com/device/K262243
Methodology: https://510kreport.com/methodology