The following data is part of a premarket notification filed by Align Technology, Inc. with the FDA for Invisalign System With Mandibular Advancement Feature.
| Device ID | K181739 |
| 510k Number | K181739 |
| Device Name: | Invisalign System With Mandibular Advancement Feature |
| Classification | Aligner, Sequential |
| Applicant | Align Technology, Inc. 2820 Orchard Pkwy San Jose, CA 95134 |
| Contact | Somi Ekwealor |
| Correspondent | Somi Ekwealor Align Technology, Inc. 2820 Orchard Pkwy San Jose, CA 95134 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2018-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816063020530 | K181739 | 000 |
| 00816063020592 | K181739 | 000 |
| 00816063020523 | K181739 | 000 |
| 00816063021360 | K181739 | 000 |
| 00816063021636 | K181739 | 000 |
| 00816063022169 | K181739 | 000 |
| 00816063022152 | K181739 | 000 |
| 00816063022145 | K181739 | 000 |