The following data is part of a premarket notification filed by American Orthodontics with the FDA for Diastema Closing Kit.
| Device ID | K893542 |
| 510k Number | K893542 |
| Device Name: | DIASTEMA CLOSING KIT |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Contact | Paul Riddle |
| Correspondent | Paul Riddle 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 | 1989-05-08 |
| Decision Date | 1989-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190746074516 | K893542 | 000 |
| 00190746074509 | K893542 | 000 |