# K120852: Zirconia Blanks (Zircostar)

- Pathway: 510(k) (Abbreviated)
- Applicant: Kerox, Ltd.
- Decided: Jun 6, 2012 after 77 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: 8 generations back to K830955 (1983). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093748: DD Bio Z and DD Bio Z - Transpa, Dental Direkt of Amerika UG (Haftungsbeschraenkt) (2010) Summary page 2.

## Indications for use
Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

Source page: https://510kreport.com/device/K120852
Methodology: https://510kreport.com/methodology