The following data is part of a premarket notification filed by Tp Orthodontics, Inc. with the FDA for Right-on Adhesive Bouding System.
| Device ID | K952643 |
| 510k Number | K952643 |
| Device Name: | RIGHT-ON ADHESIVE BOUDING SYSTEM |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | TP ORTHODONTICS, INC. 100 CENTER PLAZA Laporte, IN 46350 -0073 |
| Contact | Nancy S Iatarola |
| Correspondent | Nancy S Iatarola TP ORTHODONTICS, INC. 100 CENTER PLAZA Laporte, IN 46350 -0073 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-09 |
| Decision Date | 1995-07-11 |