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 |