Clearance Summary
Archworx received FDA 510(k) clearance under submission number K173738, sponsored by Utah Medical Products and Services. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-02-26.
- Submission: K173738
- Applicant / Sponsor: Utah Medical Products and Services
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2021-02-26
Classification & Regulation
This clearance is catalogued under FDA product code NXC and 21 CFR 872.5470, within the Dental review panel as a Class II device.