# K121980: Zirprime

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Oct 19, 2012 after 105 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 indicated in the anterior and posterior segments for: * crowns * telescopic primary crowns * multi-unit bridges (with no more than two pontics between abutment crowns) Zirprime can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of telescopic primary crowns the substructure is not veneered.

Source page: https://510kreport.com/device/K121980
Methodology: https://510kreport.com/methodology