510(k) K140432
K140432 is an FDA 510(k) premarket notification submitted by Dentall Corporation for the device "HI-LIGHT, HI-LIGHT PLUS". The FDA issued a decision of Substantially Equivalent on Aug 3, 2015. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2015
- Date Received
- Feb 20, 2014
- 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
- 510(k)