Data / Medical devices / United States / New England Orthodontic Laboratory
New England Orthodontic Laboratory: FDA-registered device maker in Andover, MA, United States, 2 510(k) clearances
New England Orthodontic Laboratory is registered with the FDA (registration 3015595297) in Andover, MA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015595297
- Address
- 3 Riverside Dr Ste 1, Andover, MA, United States, 01810
- Owner or operator
- New England Orthodontic Laboratory (10074294)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 15, 2021
- Registered through
- 2026
- Brand names listed
- NEOLab Clear Aligners
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2021 | K203339 | NEOLab Clear Aligners | NXC | Substantially Equivalent | New England Ortho Lab, Inc. | accessdata.fda.gov |
| September 28, 2020 | K202685 | Eon Aligner | NXC | Substantially Equivalent | Eon Dental Jordan, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 6, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.