# K143071: Nacera Pearl

- Pathway: 510(k) (Traditional)
- Applicant: Doceram Medical Ceramics GmbH
- Decided: Jun 26, 2015 after 242 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: 8 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)
- K080195: Nacera Z and Nacera Z Medium, Doceram Medical Ceramics GmbH (2008) Summary page 4.
- K132102: Bece Cad Zirkon HT+, Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO (2013) Summary page 4.
- K133213: Starceram, H.C. Starck Ceramics GmbH (2013) Summary page 4.

## Cited in the summary but kept off the family tree
- K117210: ZENO Zr. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Indications for use
Nacera Pearl blanks are indicated for the fabrication of single crowns and bridgework: » fully anatomical single crowns and bridgework (FCZ2) » Partially veneered or fully veneered crowns and bridges > Inlays, onlays, and Maryland bridges » Primary telescopic crowns for anterior and posterior applications

Source page: https://510kreport.com/device/K143071
Methodology: https://510kreport.com/methodology