The following data is part of a premarket notification filed by American Orthodontics with the FDA for Performed Template W/fragrance For Tooth Postioner.
| Device ID | K904128 |
| 510k Number | K904128 |
| Device Name: | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER |
| Classification | Positioner, Tooth, Preformed |
| Applicant | AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Contact | William C Machata |
| Correspondent | William C Machata AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-05 |
| Decision Date | 1990-11-09 |