Clearance Summary
Pro M Class received FDA 510(k) clearance under submission number K213897, sponsored by Saeyang Microtech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-09-19.
- Submission: K213897
- Applicant / Sponsor: Saeyang Microtech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2022-09-19
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.