# K143656: StarCeram® Z-Nature, StarCeram® Z-Smile

- Pathway: 510(k) (Traditional)
- Applicant: H.C. Starck Ceramics GmbH
- Decided: Jul 9, 2015 after 198 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: 9 generations back to K830955 (1983). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133213: Starceram, H.C. Starck Ceramics GmbH (2013) Summary page 4.
- K140924: Starceram, H.C. Starck Ceramics GmbH (2014) Summary page 4.
- K150196: DD cubeX2, Dental Direkt GmbH (2015). Cleared while this submission was under review Summary page 4.

## Indications for use
Dental Blanks made from StarCeram® Z-Nature are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges. Dental Blanks made from StarCeram® Z-Smile are indicated for crowns and bridges, multi-unit bridges, inlay bridges and all-ceramic restoration as max three-unit bridge at the anterior and posterior area.

Source page: https://510kreport.com/device/K143656
Methodology: https://510kreport.com/methodology