# K162323: Tooth Shade Resin Material

- Pathway: 510(k) (Traditional)
- Applicant: Liaoning Upcera Co., Ltd.
- Decided: Jan 12, 2017 after 146 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: 2 generations back to K920425 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative, 3M Espe Dental Products (2011) Summary page 4.

## Indications for use
“Hyramic CAD/CAM Restorative” is used for dental restorations, such as full crowns, inlays/onlays and veneers.

Source page: https://510kreport.com/device/K162323
Methodology: https://510kreport.com/methodology