# K990779: Hemaseal & Cide

- Pathway: 510(k) (Traditional)
- Applicant: Advantage Dental Products, Inc.
- Decided: Nov 17, 1999 after 253 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K161077: RnD TE and RnD SE (2017), 0 descendants of its own

## Indications for use
HEMASEAL & CIDE is to be used to seal dentinal tubules in cavity preparations or sensitive root surfaces. It also aids in wetting for tubules to provide a better bond for resin fillings and cements.

Source page: https://510kreport.com/device/K990779
Methodology: https://510kreport.com/methodology