# K081263: Starceram

- Pathway: 510(k) (Abbreviated)
- Applicant: H.C. Starck Ceramics GmbH & Co.Kg
- Decided: Jul 1, 2008 after 57 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). 21 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051462: Modification to: Cercon Base, Dentsply Intl. (2005) Summary page 1.
- K062695: Sagemax Z-Blank, Sagemax Bioceramics, Inc. (2006) Summary page 1.
- K072569: Metoxit Cam-Blanks, Metoxit AG (2007) Summary page 1.

## Most influential descendants
- K093748: DD Bio Z and DD Bio Z - Transpa (2010), 13 descendants of its own
- K150196: DD cubeX2 (2015), 9 descendants of its own
- K142987: DD Bio Z, DD Bio ZX (square), DD BioZX (square) color (2015), 7 descendants of its own
- K171585: LUXEN Zr, LUXEN Smile (2018), 5 descendants of its own
- K133213: Starceram (2013), 3 descendants of its own

## Indications for use
Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-AI-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

Source page: https://510kreport.com/device/K081263
Methodology: https://510kreport.com/methodology