510(k) K061395
K061395 is an FDA 510(k) premarket notification submitted by Addent, Inc. for the device "CALSET COMPOSITE HEATER". The FDA issued a decision of Substantially Equivalent on June 23, 2006. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Addent, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2006
- Date Received
- May 19, 2006
- 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