510(k) K013500
K013500 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO POLYLUX II". The FDA issued a decision of Substantially Equivalent on Jan 14, 2002. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Kavo America has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 14, 2002
- Date Received
- Oct 22, 2001
- 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)