# K202790: Syntec Orthodontic Mini Screw Extended System

- Pathway: 510(k) (Special)
- Applicant: Syntec Scientific Corporation
- Decided: Sep 17, 2021 after 360 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 screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

Source page: https://510kreport.com/device/K202790
Methodology: https://510kreport.com/methodology