# K081850: Bisque Zirconia Blanks, Type Byz

- Pathway: 510(k) (Traditional)
- Applicant: Zircar Zirconia, Inc.
- Decided: Sep 25, 2008 after 87 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: 6 generations back to K830955 (1983). 15 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062695: Sagemax Z-Blank, Sagemax Bioceramics, Inc. (2006) Summary page 2.
- K022996: Vita in-Ceram YZ Cubes for Cerec, Vident (2002) Summary page 2.

## Most influential descendants
- K093560: Upcera Zirconia Blanks (2010), 41 descendants of its own
- K141724: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (2014), 25 descendants of its own
- K111291: Aidite Zirconia Dental Ceramics (2011), 7 descendants of its own
- K160367: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (2016), 6 descendants of its own
- K203590: Perfit FS Dental Zirconia Fully Sintered Block (2021), 4 descendants of its own

## Indications for use
Bisque Zirconia Blanks, Type BYZ are indicated for use as a substructure for ceramic dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.

Source page: https://510kreport.com/device/K081850
Methodology: https://510kreport.com/methodology