The following data is part of a premarket notification filed by Clearpath Orthodontics Ltd with the FDA for Clearpath Aligner.
| Device ID | K162609 |
| 510k Number | K162609 |
| Device Name: | ClearPath Aligner |
| Classification | Aligner, Sequential |
| Applicant | ClearPath Orthodontics Ltd 6-N, Main Boulevard Johar Town, PK |
| Contact | Waqas Wahab |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, MD 20815 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2017-07-06 |
| Summary: | summary |