Submission Details
| 510(k) Number | K033221 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 2003 |
| Decision Date | October 28, 2003 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K033221 is an FDA 510(k) clearance for the KAVO EVEREST ZH-BLANK, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Kavo America Corporation (Deer Field, US). The FDA issued a Cleared decision on October 28, 2003, 25 days after receiving the submission on October 3, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K033221 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 2003 |
| Decision Date | October 28, 2003 |
| Days to Decision | 25 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 |