# K043472: Medin Tech Zirconia-CP10, SS1000

- Pathway: 510(k) (Traditional)
- Applicant: Medin Tech
- Decided: Jan 18, 2005 after 33 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: 4 generations back to K830955 (1983). 11 ancestors in all.
80 later devices descend from it; 3 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023327: Cynovad Zirkon, Cynovad (2002) Summary page 1.
- 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.

## Most influential descendants
- 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
- K081263: Starceram (2008), 17 descendants of its own

## Indications for use
For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for surgical implant and more recently for many uses in the dental industry. Intended for preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently will be used with porcelain overlay for translucence and related effects. Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Source page: https://510kreport.com/device/K043472
Methodology: https://510kreport.com/methodology