Clearance Summary
Premium Plus C01/C02 LED Curing Light received FDA 510(k) clearance under submission number K153514, sponsored by Premium Plus International Limited. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-08-22.
- Submission: K153514
- Applicant / Sponsor: Premium Plus International Limited
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2016-08-22
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.