Clearance Summary
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT received FDA 510(k) clearance under submission number K081287, sponsored by Den-Mat Holdings, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-11-21.
- Submission: K081287
- Applicant / Sponsor: Den-Mat Holdings, LLC
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2008-11-21
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.