Clearance Summary
LEDEX received FDA 510(k) clearance under submission number K221194, sponsored by Dentmate Technology Co. , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-09-16.
- Submission: K221194
- Applicant / Sponsor: Dentmate Technology Co. , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2022-09-16
Classification & Regulation
This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.