# K182929: BIO-RAY A-1 Anchor Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Microware Precision Co., Ltd.
- Decided: Nov 6, 2019 after 380 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: 9 generations back to K894844 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090476: Syntec Orthodontic Mini Screw, Syntec Scientific Corp. (2009) Summary page 4.

## Indications for use
The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It’s used temporarily and intended to be removed after orthodontic treatment has been completed. The screw is intended for single use only.

Source page: https://510kreport.com/device/K182929
Methodology: https://510kreport.com/methodology