510(k) K150585
K150585 is an FDA 510(k) premarket notification submitted by CAO Group, Inc. for the device "Ascent 3D". The FDA issued a decision of Substantially Equivalent on December 31, 2015. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. CAO Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 2015
- Date Received
- March 9, 2015
- Clearance Type
- Abbreviated
- 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