The following data is part of a premarket notification filed by Highland Metals with the FDA for Nitinol, Niti.
| Device ID | K935638 |
| 510k Number | K935638 |
| Device Name: | NITINOL, NITI |
| Classification | Wire, Orthodontic |
| Applicant | HIGHLAND METALS 1801 ALMADEN RD. UNIT C San Jose, CA 95125 |
| Contact | Kenneth Highland |
| Correspondent | Kenneth Highland HIGHLAND METALS 1801 ALMADEN RD. UNIT C San Jose, CA 95125 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-23 |
| Decision Date | 1994-05-18 |