# K191631: ZMAXX Dental Zirconia Blanks

- Pathway: 510(k) (Traditional)
- Applicant: Zmaxx Bioceramics, LLC
- Decided: Nov 1, 2019 after 135 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: 10 generations back to K830955 (1983). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160367: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Nissin-Metec China Co., Ltd. (2016) Summary page 5.

## Indications for use
ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Source page: https://510kreport.com/device/K191631
Methodology: https://510kreport.com/methodology