The following data is part of a premarket notification filed by American Orthodontics with the FDA for Acid Etchant.
| Device ID | K172953 |
| 510k Number | K172953 |
| Device Name: | Acid Etchant |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 |
| Contact | Trang Adams |
| Correspondent | Trang Adams American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-02-06 |
| Summary: | summary |