FDA applicant

Keystone Industries

Gibbstown, NJ3 decisions2019–20251 recall

FDA records 3 decisions for Keystone Industries (Gibbstown, NJ) from 2019 to 2025: 3 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and MQC (Mouthguard, Prescription). Since 2016 its 510(k)s took a median of 188 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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 Keystone Industries’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2021

2019high 1 (2021) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Keystone Industries by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Keystone”

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

Keystone Dental, Inc. 8 Keystone X-Ray, Inc. 4 Keystone Veterinary Supplies, Inc. 3 Keystone Diagnostics, Inc. 2 Keystone Medical 2 Keystone Heart, Ltd. 1

Keystone Industries

Which product codes does it file in?

How long do its 510(k) reviews take?

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Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Keystone”