# K243254: Parkell Pit and Fissure Sealant

- Pathway: 510(k) (Abbreviated)
- Applicant: Parkell, Inc.
- Decided: Aug 8, 2025 after 297 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 K161580 (2016). 1 ancestor in all.
1 later device descends 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)
- K161580: Premier Sealant, Premier Dental Company Products (2016) Summary page 7.

## Most influential descendants
- K260819: Any-Com Seal (2026), 0 descendants of its own

## Indications for use
The Parkell Pit and Fissure Sealant is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations.

Source page: https://510kreport.com/device/K243254
Methodology: https://510kreport.com/methodology