K181739 is an FDA 510(k) clearance for the Invisalign System with Mandibular Advancement Feature. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on October 26, 2018, 116 days after receiving the submission on July 2, 2018.
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 | K181739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2018 |
| Decision Date | October 26, 2018 |
| Days to Decision | 116 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. |