# K063770: Alpha-Bio Orthodontic Fixation Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Alpha-Bio Tec, Ltd.
- Decided: Mar 26, 2007 after 96 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894844 (1990). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031936: Osteomed Orthodontic Screw System, Osteomed LP (2004) Summary page 1.

## Most influential descendants
- K072917: JJG Evolution Orthodontic Implant System (2008), 0 descendants of its own

## Indications for use
Alpha Bio Orthodontic Fixation Screw System® are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

Source page: https://510kreport.com/device/K063770
Methodology: https://510kreport.com/methodology