# K160203: Adamant Zirconia Disc

- Pathway: 510(k) (Traditional)
- Applicant: Adamant Co., Ltd.
- Decided: Oct 19, 2016 after 265 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 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 4.
- K150196: DD cubeX2, Dental Direkt GmbH (2015) Summary page 4.

## Indications for use
Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multi-unit bridges (up to a maximum of three elements). Applications include both anterior and posterior regions.

Source page: https://510kreport.com/device/K160203
Methodology: https://510kreport.com/methodology