# K223632: Premier's MultiMatch Universal Chameleon Restorative Composite

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Company
- Decided: Dec 6, 2022 after 1 day
- 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: 2 generations back to K082671 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162257: P1145 Dental Restorative, Kerr Corporation (2016) Summary page 4.

## Indications for use
Premier’s MultiMatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include repair of enamel defects, repair of provisionals, and repair of porcelain restorations, minor occlusal build-ups, core build-ups, and incisal abrasions.

Source page: https://510kreport.com/device/K223632
Methodology: https://510kreport.com/methodology