# K163117: Alpha Pure

- Pathway: 510(k) (Traditional)
- Applicant: Koroad America
- Decided: May 9, 2017 after 183 days
- Product code: NJM (Bracket, Ceramic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- 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 K073045 (2007). 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)
- K073045: Sapphire Ceramic Bracket, Ortho Technology, Inc. (2007) Summary page 4.

## Most influential descendants
- K201038: Luce Ceramic Bracket (2020), 0 descendants of its own

## Indications for use
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.

Source page: https://510kreport.com/device/K163117
Methodology: https://510kreport.com/methodology