# K120159: Beauticem SA

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Jun 18, 2012 after 151 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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
BeautiCem SA is intended for cementation of dental restorations, dental restorative materials and prostheses to intraoral hard tissues, specifically intended for cementation of restorations (inlays, onlays, crowns, bridges, etc.) made of metal, ceramics (porcelain, alumina, or zirconia) or resin material to natural teeth. BeautiCem SA is also intended for cementation of indirectly prepared metal-core or resin-core to natural teeth.

Source page: https://510kreport.com/device/K120159
Methodology: https://510kreport.com/methodology