# K190998: BA Pit & Fissure Sealant

- Pathway: 510(k) (Abbreviated)
- Applicant: Apex Dental Materials, Inc.
- Decided: Nov 8, 2019 after 206 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: 2 generations back to K020287 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172169: Pulpdent (Activa) Pit and Fissure Sealant with MCP, Pulpdent Corporation (2018) Summary page 4.

## Indications for use
BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the enamel, in the biting surfaces of teeth. For dental professional use only.

Source page: https://510kreport.com/device/K190998
Methodology: https://510kreport.com/methodology