The following data is part of a premarket notification filed by Midwest Orthodontic Mfg. with the FDA for Orthodontic Braces.
| Device ID | K981433 |
| 510k Number | K981433 |
| Device Name: | ORTHODONTIC BRACES |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | MIDWEST ORTHODONTIC MFG. 4570 PROGRESS DR. Columbus, IN 47201 |
| Contact | Jeffrey L Fasnacht |
| Correspondent | Jeffrey L Fasnacht MIDWEST ORTHODONTIC MFG. 4570 PROGRESS DR. Columbus, IN 47201 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-20 |
| Decision Date | 1998-06-25 |