# K991161: Hydro-Cast Acrylic Varnish, Model 78125

- Pathway: 510(k) (Traditional)
- Applicant: Kay See Dental Mfg. Co.
- Decided: Apr 29, 1999 after 22 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892452 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892452: Palaseal (R), Kulzer, Inc. (1989) Summary page 3.

## Indications for use
Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic.

Source page: https://510kreport.com/device/K991161
Methodology: https://510kreport.com/methodology