# K973541: Medental Chemical Curing Sealant Pit & Fissure Tinted

- Pathway: 510(k) (Traditional)
- Applicant: Medental Intl.
- Decided: Nov 25, 1997 after 68 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- 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
This is a chemically activated sealant that is used to seal the pit and fissures found in young teeth. This sealant assures complete cure in deep fissures.

Source page: https://510kreport.com/device/K973541
Methodology: https://510kreport.com/methodology