# K162967: nuance UNIVERSAL

- Pathway: 510(k) (Traditional)
- Applicant: Den-Mat Holdings, LLC
- Decided: Mar 24, 2017 after 151 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: 9 generations back to K931812 (1993). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063595: Clearfil Majesty Posterior, Kuraray America, Inc. (2007) Summary page 4.

## Indications for use
1) Direct restorations of anterior or posterior teeth (Class I — Class V) 2) Diastema closures 3) Intraoral repairs of fractured crowns/bridges

Source page: https://510kreport.com/device/K162967
Methodology: https://510kreport.com/methodology