K933379 is an FDA 510(k) clearance for the STAINLESS STEEL ARCHES. This device is classified as a Wire, Orthodontic (Class I - General Controls, product code DZC).
Submitted by Highland Metals (San Jose, US). The FDA issued a Cleared decision on November 12, 1993, 126 days after receiving the submission on July 9, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K933379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 1993 |
| Decision Date | November 12, 1993 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZC — Wire, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |