# K161219: Zmaxx T Series

- Pathway: 510(k) (Traditional)
- Applicant: Maxx Digm, Inc.
- Decided: Jan 26, 2017 after 272 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: 3 generations back to K022996 (2002). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091096: Naturaz Series, Model B16,B20, B42, B60, B98, B100, Dental Solutions, Inc. (2009) Summary page 4.
- K143330: BruxZir Anterior, Prismatik Dentalcraft, Inc. (2014) Summary page 4.

## Most influential descendants
- K250826: Multi M Series (2025), 0 descendants of its own

## Indications for use
Zmaxx T Series is used in the manufacture of dental prosthetics.

Source page: https://510kreport.com/device/K161219
Methodology: https://510kreport.com/methodology