510(k) Report

FDA applicant

3D Smile USA, Inc.

Philadelphia, PA1 decision2020–20200 recalls

FDA records 1 decision for 3D Smile USA, Inc. (Philadelphia, PA) in 2020: 1 510(k) clearance. 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 3D Smile USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — 3D Smile USA, 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, Sequential1decision

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?

  • K2002143D Predict3D Smile USA, Inc. · 2020

The one decision as 3D Smile USA, Inc. →