Clearance Summary
ELEC Master, ELEC Master Dual received FDA 510(k) clearance under submission number K202963, sponsored by Mgnewton , 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 2023-05-05.
- Submission: K202963
- Applicant / Sponsor: Mgnewton , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2023-05-05
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.