# K111383: Zirprime

- Pathway: 510(k) (Traditional)
- Applicant: Noritake Co., Inc.
- Decided: Aug 12, 2011 after 87 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Zirprime is intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations.

Source page: https://510kreport.com/device/K111383
Methodology: https://510kreport.com/methodology