# K120109: Super Seal Tooth Desensitizer

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Dental, Inc.
- Decided: Mar 7, 2012 after 54 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: 2 generations back to K030922 (2003). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050486: Protect Tooth Desensitizer, Sunstar Butler (2005) Summary page 1.
- K041680: Orajel Advanced Tooth Desensitizer, Del Pharmaceuticals, Inc. (2004) Summary page 1.

## Most influential descendants
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K241489: ReminGel (2025), 1 descendant of its own
- K122708: Remesense for Sensitive Teeth (2013), 1 descendant of its own
- K262243: Profisil Free (2026), 0 descendants of its own
- K132426: Sylphar Remesense Sensitivity Relief Strips (2014), 0 descendants of its own

## Indications for use
To aid in the relief from dentinal sensitivity This could be caused by: Cold Heat Acids Sweets Result from dental whitening agents

Source page: https://510kreport.com/device/K120109
Methodology: https://510kreport.com/methodology