The following data is part of a premarket notification filed by Wonder Wire with the FDA for Coated Orthodontic Devices.
| Device ID | K931631 |
| 510k Number | K931631 |
| Device Name: | COATED ORTHODONTIC DEVICES |
| Classification | Wire, Orthodontic |
| Applicant | WONDER WIRE P.O. BOX 6499 Wyomissing, PA 19610 |
| Contact | Arthur L Wool |
| Correspondent | Arthur L Wool WONDER WIRE P.O. BOX 6499 Wyomissing, PA 19610 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-02 |
| Decision Date | 1993-07-28 |