510(k) K030607
K030607 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES". The FDA issued a decision of Substantially Equivalent on May 2, 2003. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Kavo America has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2003
- Date Received
- February 26, 2003
- Clearance Type
- Traditional
- 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