The following data is part of a premarket notification filed by American Orthodontics with the FDA for Bracepaste Band And Build Lc.
| Device ID | K202276 |
| 510k Number | K202276 |
| Device Name: | BracePaste Band And Build LC |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 |
| Contact | Andre Leak |
| Correspondent | Rafael Aguila Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-11 |
| Decision Date | 2020-08-14 |