Clearance Summary
LEDEX received FDA 510(k) clearance under submission number K131042, sponsored by Dentmate Technology 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 2013-10-03.
- Submission: K131042
- Applicant / Sponsor: Dentmate Technology Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2013-10-03
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.