# K081253: Zirdent Cad/Cam Blocks

- Pathway: 510(k) (Traditional)
- Applicant: C5 Medical Werks, Inc.
- Decided: May 15, 2008 after 13 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). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050160: Katana Zirconia, Noritake Co., Inc. (2005) Summary page 1.
- K070045: Zirblank-PS and Zirblank-FS, Acucera, Inc. (2007) Summary page 1.
- K061804: Zerion Alpha, ; Zerion Beta, Etkon International GmbH (2006) Summary page 1.
- K050903: Xawex G 100, Wieland Dental + Technik GmbH & Co. KG (2005) Summary page 1.

## Most influential descendants
- K091362: Ceramic Pedatric Preformed Crown (2009), 0 descendants of its own

## Indications for use
ZirDentTM CAD/CAM Blocks are pre-formed ceramic dental blanks intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations (porcelain teeth).

Source page: https://510kreport.com/device/K081253
Methodology: https://510kreport.com/methodology