# K021805: Seal & Protect Protective Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Aug 19, 2002 after 77 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.
4 later devices descend from it; 1 cites it directly.
0 of 14 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 1.

## Most influential descendants
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own
- K183391: Novidia Universal Bond (2019), 0 descendants of its own
- K122522: Dentoetch Quickbond Bond Activator (2013), 0 descendants of its own
- K070956: SEA2 Self Etch Adhesive (2007), 0 descendants of its own

## Indications for use
Seal & Protect Protective Sealant 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/K021805
Methodology: https://510kreport.com/methodology