# K161580: Premier Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Company Products
- Decided: Oct 18, 2016 after 132 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K243254: Parkell Pit and Fissure Sealant (2025), 1 descendant of its own
- K260819: Any-Com Seal (2026), 0 descendants of its own

## Indications for use
Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or “initial layer” of composite restorations.

Source page: https://510kreport.com/device/K161580
Methodology: https://510kreport.com/methodology