# K131357: PEAK Z

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Sep 6, 2013 after 119 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931812 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091705: Primer Plus, Bisco, Inc. (2009) Summary page 1.

## Indications for use
Peak Z is intended for use as a surface treatment for restorations made of the following materials: Zirconia Aluminum oxide Metal/Alloy Titanium

Source page: https://510kreport.com/device/K131357
Methodology: https://510kreport.com/methodology