K162609 is an FDA 510(k) clearance for the ClearPath Aligner. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Clearpath Orthodontics, Ltd. (Johar Town, PK). The FDA issued a Cleared decision on July 6, 2017, 290 days after receiving the submission on September 19, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion..
| 510(k) Number | K162609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2016 |
| Decision Date | July 06, 2017 |
| Days to Decision | 290 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NXC - Aligner, Sequential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion. |