# K061997: Premier Self-Etching Enamel Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Co.
- Decided: Oct 4, 2006 after 82 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K091632: SPK Sealant (2009), 2 descendants of its own
- K100062: Infiltration Kit (2010), 1 descendant of its own
- K251124: G-Bond Universal (2025), 0 descendants of its own

## Indications for use
Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.

Source page: https://510kreport.com/device/K061997
Methodology: https://510kreport.com/methodology