# K151699: BEAUTIFIL II Enamel

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Dec 10, 2015 after 169 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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
BEAUTIFIL IT Enamel is a light-cured radiopaque restorative material, designed for anterior restorations as well as posterior restorations including for restorations involving occlusal surfaces. It can also be used for repair of restorations and prostheses. * Direct anterior and posterior restorations (except for tooth root) * Repair of restorations and prostheses

Source page: https://510kreport.com/device/K151699
Methodology: https://510kreport.com/methodology