# K062695: Sagemax Z-Blank

- Pathway: 510(k) (Traditional)
- Applicant: Sagemax Bioceramics, Inc.
- Decided: Oct 20, 2006 after 39 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: 5 generations back to K830955 (1983). 13 ancestors in all.
76 later devices descend from it; 8 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050903: Xawex G 100, Wieland Dental + Technik GmbH & Co. KG (2005) Summary page 1.
- K043472: Medin Tech Zirconia-CP10, SS1000, Medin Tech (2005) Summary page 1.
- 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.

## Most influential descendants
- 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
- K093748: DD Bio Z and DD Bio Z - Transpa (2010), 13 descendants of its own

## Indications for use
Intended for use in preparation of crowns, facings, inlays and onlays-to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects, 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 many uses in the dental industry Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes 1,11, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Source page: https://510kreport.com/device/K062695
Methodology: https://510kreport.com/methodology