# K111782: Beautisealant

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Sep 16, 2011 after 84 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
BeautiSealant is resin material intended for sealing of pits and fissures, which is polymerized by visible light energy (external energy). 'Primer' modifies enamel surface with its adhesive monomer to bond 'Paste' to enamel.

Source page: https://510kreport.com/device/K111782
Methodology: https://510kreport.com/methodology