# K110058: Bpa-Free Pit and Fissure Sealant

- Pathway: 510(k) (Abbreviated)
- Applicant: Novocol Inc. Dba Septodont and Confi-Dental Produc
- Decided: Mar 31, 2011 after 80 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
"BPA-Free Pit and Fissure Sealant" is indicated for the covering and sealing of pits and fissures in the occiusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.

Source page: https://510kreport.com/device/K110058
Methodology: https://510kreport.com/methodology