510(k) K233518
K233518 is an FDA 510(k) premarket notification submitted by Handpiece Headquarters for the device "BASE290 LED Curing Light". The FDA issued a decision of Substantially Equivalent on November 2, 2023. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Handpiece Headquarters has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2023
- Date Received
- November 1, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Activator, Ultraviolet, For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type