510(k) K250009
K250009 is an FDA 510(k) premarket notification submitted by Premium Plus (Dongguan) Limited for the device "LED Curing Light (C01-X, C02-X)". The FDA issued a decision of Substantially Equivalent on April 10, 2025. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Premium Plus (Dongguan) Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2025
- Date Received
- January 2, 2025
- Clearance Type
- Traditional
- 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