FDA applicant

Five Star Orthodontic Lab & Supply

Denton, TX1 decision2019–20190 recalls

FDA records 1 decision for Five Star Orthodontic Lab & Supply (Denton, TX) in 2019: 1 510(k) clearance. All are in product code NXC (Aligner, Sequential). Its devices cite 1 predicate, 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 Five Star Orthodontic Lab & Supply’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Five Star Orthodontic Lab & Supply by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Five Star Orthodontic Lab & Supply’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

Other applicant names beginning “Five”

FDA records each applicant name separately; these may or may not be the same firm.

Five Star Medical, Inc. 2 Five Lakes Co., Inc. 1 Five Stars Alloys, Ltd. 1 Five Star Rubber Products 1

Five Star Orthodontic Lab & Supply

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Five”