# K092730: Cosmedent Brushable Composite

- Pathway: 510(k) (Traditional)
- Applicant: Cosmedent, Inc.
- Decided: Nov 20, 2009 after 77 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
Longest line of descent: 1 generation back to K030585 (2003). 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)
- K030585: Sculpting Resin, Bisco, Inc. (2003) Summary page 1.

## Indications for use
BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, and repair of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

Source page: https://510kreport.com/device/K092730
Methodology: https://510kreport.com/methodology