# K142001: Syntec Wetali Orthodontic Mini Screws

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corporation - Taipei Office
- Decided: Mar 18, 2015 after 238 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.
1 later device descends from it; 1 cites it directly.
0 of 23 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.

## Most influential descendants
- K202163: Mico One Orthodontic Screw (2022), 0 descendants of its own

## Indications for use
THE SCREWS ARE INDICATED FOR USE AS A FIXED ANCHORAGE FOR ATTACHMENT OF ORTHODONTIC APPLIANCES TO FACILITATE THE ORTHODONTIC MOVEMENT OF TEETH. THEY ARE USED TEMPORARILY AND ARE REMOVED AFTER ORTHODONTIC TREATMENT HAS BEEN COMPLETED. THEY ARE INTENDED FOR SINGLE USE ONLY.

Source page: https://510kreport.com/device/K142001
Methodology: https://510kreport.com/methodology