The following data is part of a premarket notification filed by Ultimate Wireforms, Inc. with the FDA for Nitinol Gentle Touch Coil Spring.
| Device ID | K923839 |
| 510k Number | K923839 |
| Device Name: | NITINOL GENTLE TOUCH COIL SPRING |
| Classification | Wire, Orthodontic |
| Applicant | ULTIMATE WIREFORMS, INC. 88 HARWINTON AVE. Terryville, CT 06786 |
| Contact | Paul J Blanchette |
| Correspondent | Paul J Blanchette ULTIMATE WIREFORMS, INC. 88 HARWINTON AVE. Terryville, CT 06786 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-30 |
| Decision Date | 1992-10-15 |