# K041680: Orajel Advanced Tooth Desensitizer

- Pathway: 510(k) (Traditional)
- Applicant: Del Pharmaceuticals, Inc.
- Decided: Nov 10, 2004 after 142 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050486: Protect Tooth Desensitizer (2005), 10 descendants of its own
- K120109: Super Seal Tooth Desensitizer (2012), 6 descendants of its own
- K082594: Remesense (2009), 3 descendants of its own
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K103461: Colgate Desensitizing Dental Cream (2011), 2 descendants of its own

## Indications for use
Tooth Desensitizer

Source page: https://510kreport.com/device/K041680
Methodology: https://510kreport.com/methodology