# K121915: Bright Restorative Materials

- Pathway: 510(k) (Traditional)
- Applicant: Dmp, Ltd.
- Decided: Sep 28, 2012 after 88 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
NANOCERAM - BRIGHT FLOW Fillings of minimally invasive cavities of all classes Fillings of small class I cavities Fillings of class Il-V cavities including V-shaped defects and cervical caries Extended fissure sealing Cavity lining - as the first layer for Class I and 11restorations Splinting of mobile teeth Blocking out of undercuts Small restorations of all types Repair of composite restorations and ceramic veneers BRIGHT FLOW CORE - BRIGHT HEAVY CORE Core build up of vital and non-vital teeth Post cementation BRIGHT LIGHT Class I-V restorations Reconstruction of affected anterior teeth Veneering of discoloured anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers BRIGHT LIGHT FLOW Fillings of minimally invasive cavities of all classes Fillings of class Il-V cavities including V-shaped defects and cervical caries Extended fissure sealing Splinting of mobile teeth Blocking out of undercuts Small restorations of all types Repair of composite restorations and ceramic veneers BRIGHT POSTERIOR Direct posterior restorations (Class I and 11), including occlusal surfaces Core build ups Splinting of mobile teeth

Source page: https://510kreport.com/device/K121915
Methodology: https://510kreport.com/methodology