K935638 is an FDA 510(k) clearance for the NITINOL, NITI. 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 May 18, 1994, 176 days after receiving the submission on November 23, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K935638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1993 |
| Decision Date | May 18, 1994 |
| Days to Decision | 176 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 |