# K011822: Pit and Fissure Chemical Curing Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Rite-Dent Manufacturing Corp.
- Decided: Aug 7, 2001 after 57 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 chemlcally activated sealant that is used to seal the pit ad fissures found in primary and secondary dentition in combination wlith the acid etching technique. This sealant assures complete cure in deep fissures.

Source page: https://510kreport.com/device/K011822
Methodology: https://510kreport.com/methodology