# K954867: Ionosit Seal

- Pathway: 510(k) (Traditional)
- Applicant: Foremost Dental Mfg., Inc.
- Decided: Mar 8, 1996 after 136 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: 1 generation back to K862284 (1986). 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)
- K862284: Sealite, Sybron Corp. (1986) Summary page 1.

## Indications for use
Ionosit Seal is a dental pit and fissure sealant intended to be used to seal the pits and fissures of occlusual non-carious posterior teeth.

Source page: https://510kreport.com/device/K954867
Methodology: https://510kreport.com/methodology