# K071742: Beautifil II

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Aug 15, 2007 after 49 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 II is a visible light curing dental filling composite resin having radiopacity, which is used for various restorations. It is suitable for filling and repairing for anterior and posterior, such as class I through V restorations, wedge shaped defects and root caries. It can be also applied to core build-up and repair of fractured laminate veneer, porcelain, composite resin and C&B materials.

Source page: https://510kreport.com/device/K071742
Methodology: https://510kreport.com/methodology