The following data is part of a premarket notification filed by Tp Orthodontics, Inc. with the FDA for Tp Orthodontics Light-cure Adhesive System, Tp Orthodontics Pre-applied Adhesive, Tp Orthodontics Etchant208520.
| Device ID | K214054 |
| 510k Number | K214054 |
| Device Name: | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | TP Orthodontics, Inc. 100 Center Plaza La Porte, IN 46350 -9672 |
| Contact | Cristiane Muller |
| Correspondent | Cristiane Muller TP Orthodontics, Inc. 100 Center Plaza La Porte, IN 46350 -9672 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-10-14 |