510(k) K140877
K140877 is an FDA 510(k) premarket notification submitted by Whip Mix Corp. for the device "VERICORE ZIRCONIA BLANKS". The FDA issued a decision of Substantially Equivalent on September 3, 2014. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Whip Mix Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2014
- Date Received
- April 7, 2014
- 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