# K102257: Nanoceram- Bright

- Pathway: 510(k) (Traditional)
- Applicant: Dmp, Ltd.
- Decided: Nov 19, 2010 after 101 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. The FDA summary names no predicate by number.

## Indications for use
Anterior restorations (Class III, IV) Posterior restorations (Class 1,11) Class V restorations (Cervical caries, root erosion, wedge shaped defects) Veneering of discolored anterior teeth Splinting of mobile teeth Repair ot composite and ceramic veneers

Source page: https://510kreport.com/device/K102257
Methodology: https://510kreport.com/methodology