# K012794: Prime-Dent Chemical Cure Pit & Fissure Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Prime Dental Manufacturing, Inc.
- Decided: Nov 5, 2001 after 76 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Prime-Dent® Chemical Cure Pit & Fissure Sealant (opaque and clear) is 2 BisGMA based visible light cured resin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.

Source page: https://510kreport.com/device/K012794
Methodology: https://510kreport.com/methodology