510(k) Report

FDA applicant

LuxCreo, Inc.

Chicago, IL5 decisions2022–20260 recalls

FDA records 5 decisions for LuxCreo, Inc. (Chicago, IL) from 2022 to 2026: 5 510(k) clearances. Most are in product codes NXC (Aligner, Sequential) and MQC (Mouthguard, Prescription). Since 2016 its 510(k)s took a median of 256 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 5 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 LuxCreo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2022: 12024: 12025: 22026 (partial year): 1
2022high 2 (2025) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — LuxCreo, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like LuxCreo, Inc.’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

Which product codes does it file in?

  • NXCAligner, Sequential2decisions
  • MQCMouthguard, Prescription1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision
  • PNNOrthodontic Software1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 256 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 98 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K212680LuxCreo Clear Aligner SystemLuxCreo, Inc. · 20223cite it

What has FDA decided for it lately?

  • K260421LuxDesignLuxCreo, Inc. · 2026
  • K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025
  • K250343LuxCreo Clear Aligner SystemLuxCreo, Inc. · 2025
  • K230592LuxCreo Dental Night Guard ResinLuxCreo, Inc. · 2024
  • K212680LuxCreo Clear Aligner SystemLuxCreo, Inc. · 2022

All 5 as LuxCreo, Inc. →