K831096 is an FDA 510(k) clearance for the STROMA II. This device is classified as a Alloy, Other Noble Metal (Class II - Special Controls, product code EJS).
Submitted by Unitek Corp. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983, 72 days after receiving the submission on April 4, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.
| 510(k) Number | K831096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1983 |
| Decision Date | June 15, 1983 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJS — Alloy, Other Noble Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3060 |