Manufacturer registered with FDA
New England Orthodontic Laboratory
Andover, MA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What New England Orthodontic Laboratory currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | NEOLab Clear Aligners | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
New England Orthodontic Laboratory lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: New England Ortho Lab, Inc. (1), Eon Dental Jordan, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Jan 2021 | K203339 | NEOLab Clear Aligners | New England Ortho Lab, Inc. | NXC Sequential Aligner |
| 28 Sep 2020 | K202685 | Eon Aligner | Eon Dental Jordan, LLC | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NEW ENGLAND ORTHODONTIC LABORATORYFDA reg. 3015595297 | Andover, MA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10074294). 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.