# K992822: Seal & Protect Protective Sealant for Exposed Dentine

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Nov 17, 1999 after 86 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: 5 generations back to K931812 (1993). 8 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System, Dentsply Intl. (1998) Summary page 1.

## Most influential descendants
- K021805: Seal & Protect Protective Sealant (2002), 4 descendants of its own
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own
- K003482: Proclude-Sensitive (2001), 3 descendants of its own
- 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

## Indications for use
SEAL & PROTECT™ DENTAL VARNISH is a protective sealant for exposed dentine. The Indications for Use are: « Reduction of abrasion and erosion of exposed cervical dentine » Treatment of hypersensitive cervical areas

Source page: https://510kreport.com/device/K992822
Methodology: https://510kreport.com/methodology