# K160367: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

- Pathway: 510(k) (Traditional)
- Applicant: Nissin-Metec China Co., Ltd.
- Decided: Jul 27, 2016 after 169 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). 18 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141724: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Liaoning Upcera Co., Ltd. (2014) Summary page 5.

## Most influential descendants
- K180252: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank (2018), 4 descendants of its own
- K190112: Non-Sterile Zirconia Block (2019), 3 descendants of its own
- K223253: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) (2023), 1 descendant of its own
- K250063: ARENA Star, Galaxy Star (2025), 0 descendants of its own
- K201492: Non-Sterile Zirconia Block (2021), 0 descendants of its own

## Indications for use
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Source page: https://510kreport.com/device/K160367
Methodology: https://510kreport.com/methodology