# K201608: GenesisZr UHT700 Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: United Dental Resources Corporation
- Decided: Jan 28, 2021 after 227 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K150872 (2015). 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)
- K160867: Pavati Z40.2 Zirconia, Ccri, Inc. (2016) Summary page 4.

## Indications for use
GenesisZr® UHT700 Zirconia blanks are indicated for Monolithic-ceramic for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration, adhesively, or non-adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration, adhesively, or non-adhesively cemented.

Source page: https://510kreport.com/device/K201608
Methodology: https://510kreport.com/methodology