# K180565: Peak NS033CF, Peak NS017CF

- Pathway: 510(k) (Traditional)
- Applicant: Neosil Co., Ltd.
- Decided: Jun 13, 2018 after 100 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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 K102836 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152180: PEAK, Neosil Co., Ltd. (2015) Summary page 4.

## Indications for use
this device is to be used as a heavy body material for: ▪ Two step putty/wash technique ▪ Sigle step putty/wash technique ▪ Functional peripheries ▪ Crown/bridge work

Source page: https://510kreport.com/device/K180565
Methodology: https://510kreport.com/methodology