K833145 is an FDA 510(k) clearance for the ZENITH. This device is classified as a Alloy, Metal, Base (Class II — Special Controls, product code EJH).
Submitted by Jeneric Ind. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983, 74 days after receiving the submission on September 15, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3710.
| 510(k) Number | K833145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | September 15, 1983 |
| Decision Date | November 28, 1983 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJH — Alloy, Metal, Base |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3710 |