FDA applicant

Lightforce Orthodontics

Burlington, MA3 decisions2020–20230 recalls

FDA records 3 decisions for Lightforce Orthodontics (Burlington, MA) from 2020 to 2023: 3 510(k) clearances. All are in product code NJM (Bracket, Ceramic, Orthodontic). Its devices cite 3 predicates, 1 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 Lightforce Orthodontics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Lightforce Orthodontics by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lightforce Orthodontics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Lightforce Orthodontics

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?