510(k) Report

FDA applicant

New England Ortho Lab, Inc.

Andover, MA2 decisions2020–20210 recalls

FDA records 2 decisions for New England Ortho Lab, Inc. (Andover, MA) from 2020 to 2021: 2 510(k) clearances. All are in product code NXC (Aligner, Sequential). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided New England Ortho Lab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 12021: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — New England Ortho Lab, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NXCAligner, Sequential2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K203339NEOLab Clear AlignersNew England Ortho Lab, Inc. · 2021
  • K192338NEOLab Clear AlignersNew England Ortho Lab, Inc. · 2020

All 2 as New England Ortho Lab, Inc. →