# K003482: Proclude-Sensitive

- Pathway: 510(k) (Traditional)
- Applicant: Ortek Therapeutics, Inc.
- Decided: Feb 1, 2001 after 84 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: 6 generations back to K931812 (1993). 9 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K992822: Seal & Protect Protective Sealant for Exposed Dentine, Dentsply Intl. (1999) Summary page 2.

## Most influential descendants
- K103461: Colgate Desensitizing Dental Cream (2011), 2 descendants of its own
- K140481: Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash (2014), 1 descendant of its own
- K143155: LISTERINE Sensitivity Defense Mouthrinse (2015), 0 descendants of its own

## Indications for use
PROCLUDE-SENSITIVE is a topical desensitizing dental cream for the management of sensitive teeth. PROCLUDE-SENSITIVE is indicated for: 1. Treatment of hypersensitivity associated with exposed root surface dentin. 2. Reduction of abrasion and erosion of exposed cervical dentin.

Source page: https://510kreport.com/device/K003482
Methodology: https://510kreport.com/methodology