# K132748: Beautifil E Posterior, Beautifil Bulk

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Dec 4, 2013 after 92 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 e Posterior / BEAUTIFIL Bulk comes in 28 shades, among which Universal and A shade (given the trade name BEAUTIFIL Bulk) provide high transparency and greater depth of cure by reducing pigment content compared to other shades. Universal and A shade (BEAUTIFIL Bulk) are intended only for direct posterior restorations. BEAUTIFIL e Posterior Direct posterior restorations Repair of restorations and prostheses BEAUTIFIL Bulk Direct posterior restorations using a light-curing resin paste to be used for masking the substructure color of dental restorations.

Source page: https://510kreport.com/device/K132748
Methodology: https://510kreport.com/methodology