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 |