The following data is part of a premarket notification filed by American Orthodontics with the FDA for Ortho-kev Appliance Reinforcing System.
| Device ID | K895714 |
| 510k Number | K895714 |
| Device Name: | ORTHO-KEV APPLIANCE REINFORCING SYSTEM |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1989-12-21 |