# K152180: PEAK

- Pathway: 510(k) (Traditional)
- Applicant: Neosil Co., Ltd.
- Decided: Oct 22, 2015 after 79 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: 1 generation back to K102836 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102836: Bonasil a+ Impression Materials, Dmp, Ltd. (2011) Summary page 5.

## Most influential descendants
- K180565: Peak NS033CF, Peak NS017CF (2018), 0 descendants of its own

## Indications for use
NS033C is to be used as a light body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Silicon dental impressions Crown/bridge work Inlays, Onlays NS017C/NS017T is to be used as a heavy body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays MSP is to be used as a putty body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays MSBC is to be used as a bite type for: Making accurate occlusal registrations Standards bite registrations in the end bite position. Key material for needle point registration. Production of small model segments MSRC is to be used as a regular body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays MSCC is to be used as a regular body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays

Source page: https://510kreport.com/device/K152180
Methodology: https://510kreport.com/methodology