# K992516: Dyract Seal Compomer Pit & Fissure Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Aug 27, 1999 after 30 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
Longest line of descent: 3 generations back to K950991 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982564: Delton FS Direct Delivery System, Dentsply Intl. (1998) Summary page 1.
- K982395: Dytract Flow Restorative, Dentsply Intl. (1998) Summary page 1.

## Indications for use
Used for preventive sealing of pits and fissures in the primary and secondary dentition.

Source page: https://510kreport.com/device/K992516
Methodology: https://510kreport.com/methodology