# K170834: Cerabien ZR

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Oct 17, 2017 after 211 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K250673: CERABIEN MiLai (2025), 1 descendant of its own
- K262195: Dandy Ceramic Stain and Glaze (2026), 0 descendants of its own

## Indications for use
For use in prosthetic dentistry to create an all-ceramic prosthesis.

Source page: https://510kreport.com/device/K170834
Methodology: https://510kreport.com/methodology