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 | K203339 |
510k Number | K203339 |
Device Name: | NEOLab Clear Aligners |
Classification | Aligner, Sequential |
Applicant | New England Ortho Lab, Inc 3 Riverside Drive Andover, MA 01810 |
Contact | Christian Saurman |
Correspondent | Olivia Channon New England Ortho Lab, Inc 3 Riverside Drive Andover, MA 01810 |
Product Code | NXC |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-12 |
Decision Date | 2021-01-06 |