# K182642: GenesisZr™ 4Y Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: United Dental Resources Corporation
- Decided: Jan 25, 2019 after 123 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: 1 generation back to K060104 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060104: Prismatik Clinical Zirconia, Glidewell Laboratories (2006) Summary page 4.

## Indications for use
GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for: - Full contour monolithic crowns and bridges in anterior and posterior regions. - Anatomically reduced for veneering, crown and bridge frames. - Bridge to be limited to 3 units with a maximum of 1 pontic.

Source page: https://510kreport.com/device/K182642
Methodology: https://510kreport.com/methodology