Clearance Summary
SYNTEC WETALI ORTHODONTIC MINI SCREWS received FDA 510(k) clearance under submission number K142001, sponsored by Syntec Scientific Corporation - Taipei Office. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-03-18.
- Submission: K142001
- Applicant / Sponsor: Syntec Scientific Corporation - Taipei Office
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2015-03-18
Classification & Regulation
This clearance is catalogued under FDA product code OAT and 21 CFR 872.3640, within the Dental review panel as a Class II device.