# K133213: Starceram

- Pathway: 510(k) (Traditional)
- Applicant: H.C. Starck Ceramics GmbH
- Decided: Dec 5, 2013 after 48 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: 7 generations back to K830955 (1983). 24 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081263: Starceram, H.C. Starck Ceramics GmbH & Co.Kg (2008) Summary page 1.
- K112710: Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR, Wieland Dental + Technik GmbH & Co. KG (2011) Summary page 1.

## Most influential descendants
- K140924: Starceram (2014), 1 descendant of its own
- K143656: StarCeram® Z-Nature, StarCeram® Z-Smile (2015), 0 descendants of its own
- K143071: Nacera Pearl (2015), 0 descendants of its own

## Indications for use
Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.

Source page: https://510kreport.com/device/K133213
Methodology: https://510kreport.com/methodology