The following data is part of a premarket notification filed by Sms Opco, Llc with the FDA for 6ms Invisible Aligner.
| Device ID | K210652 |
| 510k Number | K210652 |
| Device Name: | 6MS Invisible Aligner |
| Classification | Aligner, Sequential |
| Applicant | SMS OPCO, LLC 672 Morning Star Drive, Suite 120 The Colony, TX 75056 |
| Contact | Bruce Page |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-04 |
| Decision Date | 2021-06-02 |