FDA applicant

Den Tek Oral Care, Inc.

Washington, DC8 decisions2007–20150 recalls

FDA records 8 decisions for Den Tek Oral Care, Inc. (Washington, DC) from 2007 to 2015: 8 510(k) clearances. Most are in product codes OBR (Mouthguard, Over-The-Counter) and MQC (Mouthguard, Prescription). Its devices cite 12 predicates, 6 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 Den Tek Oral Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Den Tek Oral Care, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Den Tek Oral Care, Inc.’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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Den Tek Oral Care, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?