# K023327: Cynovad Zirkon

- Pathway: 510(k) (Traditional)
- Applicant: Cynovad
- Decided: Dec 2, 2002 after 59 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: 3 generations back to K830955 (1983). 10 ancestors in all.
91 later devices descend from it; 6 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984201: Denzir, Dentronic AB (1999) Summary page 1.
- K013230: Cercon Base, Degussa - Ney Dental, Inc. (2001) Summary page 1.
- K895901: Vita Cerec Set and Vita Cerec Blocs, Vident (1992) Summary page 1.
- K884166: Dicor Ceramic Inlay - New Technic, Dentsply Intl. (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- K001875: Diamedix IS-Rubella Igm Capture Test System, Diamedix Corp. (2000). Our reading of the summary gave K001875, FDA’s number for Diamedix IS-Rubella Igm Capture Test System (Diamedix Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Zirconium Oxide for the DCS Precident CAD/CAM System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K043472: Medin Tech Zirconia-CP10, SS1000 (2005), 80 descendants of its own
- K062695: Sagemax Z-Blank (2006), 76 descendants of its own
- K081850: Bisque Zirconia Blanks, Type Byz (2008), 43 descendants of its own
- 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

## Indications for use
Intended for preparation of crowns, facings, veneers, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, 11, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Source page: https://510kreport.com/device/K023327
Methodology: https://510kreport.com/methodology