# K091852: Bisque Zirconia Blanks, Model R610191, R610210, R610211, R610205

- Pathway: 510(k) (Traditional)
- Applicant: Refractron Technologies Corp.
- Decided: Sep 10, 2009 after 79 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: 7 generations back to K830955 (1983). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081850: Bisque Zirconia Blanks, Type Byz, Zircar Zirconia, Inc. (2008) Summary page 1.

## Indications for use
Refractron Technologies Corporation Bisque Zirconia Blanks (Type BYZ), are indicated for use as a substructure for ceramic dental restorations.

Source page: https://510kreport.com/device/K091852
Methodology: https://510kreport.com/methodology