# K230455: Enamel Coating Resin

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Jul 25, 2023 after 154 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 K992326 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992326: 3M Clinpro Sealant, 3M Company (1999) Summary page 4.

## Indications for use
Proseal Enamel Coating Resin is a light curing material for sealing the enamel pits and fissures of teeth.

Source page: https://510kreport.com/device/K230455
Methodology: https://510kreport.com/methodology