# K242458: ArgenZ MTZ

- Pathway: 510(k) (Traditional)
- Applicant: Argen Corporation
- Decided: Oct 24, 2024 after 66 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: 4 generations back to K022996 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222626: Dental Zirconia Ceramic, Aidite (Qinhuangdao) Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a full arch. All blanks are processed by dental laboratories or by dental professionals

Source page: https://510kreport.com/device/K242458
Methodology: https://510kreport.com/methodology