# K031968: Cerabien ZR

- Pathway: 510(k) (Traditional)
- Applicant: Noritake Co., Inc.
- Decided: Dec 22, 2003 after 179 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K051249: ZIROX (2005), 1 descendant of its own
- K133078: K-Etchant Syringe; Needle Tip (E) (2013), 0 descendants of its own
- K103773: Zenoflex Dimension (2011), 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/K031968
Methodology: https://510kreport.com/methodology