510(k) K032081
K032081 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60". The FDA issued a decision of Substantially Equivalent on Jul 24, 2003. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Kavo America has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2003
- Date Received
- Jul 7, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type
- 510(k)