# K091096: Naturaz Series, Model B16,B20, B42, B60, B98, B100

- Pathway: 510(k) (Traditional)
- Applicant: Dental Solutions, Inc.
- Decided: Jun 18, 2009 after 63 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: 2 generations back to K022996 (2002). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032081: Kavo Everest ZS-Blank Models, 42, 20, and 60, Kavo America (2003) Summary page 1.

## Most influential descendants
- K161219: Zmaxx T Series (2017), 1 descendant of its own
- K250826: Multi M Series (2025), 0 descendants of its own

## Indications for use
NaturaZ Series is used in the manufacture of dental prosthetics. The Dental Solution, Inc. proposes that the materials distributed within the United States be labeled: 'CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals.'

Source page: https://510kreport.com/device/K091096
Methodology: https://510kreport.com/methodology
