Not currently registered with FDA under this name
New England Ortho Lab, Inc.
Andover, MA, United States. Named as applicant on 2 dental 510(k) clearances between 2020 and 2021. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22020–2021
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names New England Ortho Lab, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Jan 2021 | K203339 | NEOLab Clear Aligners | NXC Sequential Aligner |
| 12 Mar 2020 | K192338 | NEOLab Clear Aligners | NXC Sequential Aligner |
Some of these clearances are listed with FDA today by another company: New England Orthodontic Laboratory (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.