# K050486: Protect Tooth Desensitizer

- Pathway: 510(k) (Traditional)
- Applicant: Sunstar Butler
- Decided: Jun 7, 2005 after 102 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: 1 generation back to K030922 (2003). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030922: Vivasens, Ivoclar Vivadent, Inc. (2003) Summary page 2.
- K041680: Orajel Advanced Tooth Desensitizer, Del Pharmaceuticals, Inc. (2004) Summary page 2.

## Most influential descendants
- K120109: Super Seal Tooth Desensitizer (2012), 6 descendants of its own
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K103461: Colgate Desensitizing Dental Cream (2011), 2 descendants of its own
- K241489: ReminGel (2025), 1 descendant of its own
- K140481: Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash (2014), 1 descendant of its own

## Indications for use
ProtectTM Tooth Desensitizer is a film-like varnish indicated for the treatment of tooth sensitivities.

Source page: https://510kreport.com/device/K050486
Methodology: https://510kreport.com/methodology