510(k) K142670
K142670 is an FDA 510(k) premarket notification submitted by Whip Mix Corporation for the device "Vericore Zirconia Blanks". The FDA issued a decision of Substantially Equivalent on October 22, 2014. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Whip Mix Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2014
- Date Received
- September 19, 2014
- 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