K022252 is an FDA 510(k) clearance for the STERNGOLD 1, MODEL 1127781. This device is classified as a Alloy, Other Noble Metal (Class II - Special Controls, product code EJS).
Submitted by Sterngold (Attleboro, US). The FDA issued a Cleared decision on September 19, 2002, 69 days after receiving the submission on July 12, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.
| 510(k) Number | K022252 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2002 |
| Decision Date | September 19, 2002 |
| Days to Decision | 69 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJS — Alloy, Other Noble Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3060 |