The following data is part of a premarket notification filed by American Orthodontics with the FDA for Orthodontic Metal Bracket.
| Device ID | K923261 |
| 510k Number | K923261 |
| Device Name: | ORTHODONTIC METAL BRACKET |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Contact | Paul Riddlee |
| Correspondent | Paul Riddlee AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-02 |
| Decision Date | 1992-12-03 |