# K092630: ZIROX

- Pathway: 510(k) (Traditional)
- Applicant: Zencera, Inc.
- Decided: Oct 22, 2009 after 56 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.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013230: Cercon Base, Degussa - Ney Dental, Inc. (2001) Summary page 2.
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001) Summary page 2.
- K062695: Sagemax Z-Blank, Sagemax Bioceramics, Inc. (2006) Summary page 2.

## Most influential descendants
- K100250: Xceram (2010), 0 descendants of its own

## Indications for use
The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Source page: https://510kreport.com/device/K092630
Methodology: https://510kreport.com/methodology