Submission Details
| 510(k) Number | K142670 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2014 |
| Decision Date | October 22, 2014 |
| Days to Decision | 33 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K142670 is an FDA 510(k) clearance for the Vericore Zirconia Blanks, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Whip Mix Corporation (Louisville, US). The FDA issued a Cleared decision on October 22, 2014, 33 days after receiving the submission on September 19, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K142670 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2014 |
| Decision Date | October 22, 2014 |
| Days to Decision | 33 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.6660 |