Submission Details
| 510(k) Number | K801524 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1980 |
| Decision Date | July 21, 1980 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K801524 is an FDA 510(k) clearance for the ZEST PLANT. This device is classified as a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE).
Submitted by Zest Anchors, Inc. (Walker, US). The FDA issued a Cleared decision on July 21, 1980, 20 days after receiving the submission on July 1, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K801524 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1980 |
| Decision Date | July 21, 1980 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3640 |