510(k) K223142
K223142 is an FDA 510(k) premarket notification submitted by Dent4you AG for the device "Coltolux Comfort LED Curing Light". The FDA issued a decision of Substantially Equivalent on December 22, 2022. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Dent4you AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2022
- Date Received
- October 4, 2022
- 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