The following data is part of a premarket notification filed by American Orthodontics with the FDA for An Alternative Direct Bonding Ortho. System.
| Device ID | K893396 |
| 510k Number | K893396 |
| Device Name: | AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| 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 | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-01 |
| Decision Date | 1989-06-23 |