510(k) K172426
K172426 is an FDA 510(k) premarket notification submitted by Promident, LLC for the device "Clear Blue Digi LED Curing Light". The FDA issued a decision of Substantially Equivalent on Aug 16, 2017. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Promident, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 2017
- Date Received
- Aug 10, 2017
- 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
- 510(k)