510(k) K153514
K153514 is an FDA 510(k) premarket notification submitted by Premium Plus International Limited for the device "Premium Plus C01/C02 LED Curing Light". The FDA issued a decision of Substantially Equivalent on August 22, 2016. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Premium Plus International Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2016
- Date Received
- December 7, 2015
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Activator, Ultraviolet, For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type