The following data is part of a premarket notification filed by New England Ortho Lab, Inc. with the FDA for Neolab Clear Aligners.
| Device ID | K192338 |
| 510k Number | K192338 |
| Device Name: | NEOLab Clear Aligners |
| Classification | Aligner, Sequential |
| Applicant | New England Ortho Lab, Inc. 3 Riverside Drive Andover, MA 01810 |
| Contact | Olivia Channon |
| 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 | 2019-08-28 |
| Decision Date | 2020-03-12 |