# K162257: P1145 Dental Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Nov 7, 2016 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
Longest line of descent: 1 generation back to K082671 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082671: Herculite Ultra, Sybron Dental Specialties (2008) Summary page 4.

## Most influential descendants
- K223632: Premier's MultiMatch Universal Chameleon Restorative Composite (2022), 0 descendants of its own

## Indications for use
P1145, a nanohybrid dental restorative, is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, core build-ups and incisal abrasions.

Source page: https://510kreport.com/device/K162257
Methodology: https://510kreport.com/methodology