510(k) Report

FDA applicant

Ortek Therapeutics, Inc.

New York, NY3 decisions2000–20170 recalls

FDA records 3 decisions for Ortek Therapeutics, Inc. (New York, NY) from 2000 to 2017: 3 510(k) clearances. Most are in product codes NBL (Light-Induced Fluorescence Caries Detector) and EJR (Agent, Polishing, Abrasive, Oral Cavity). Its devices cite 3 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 Ortek Therapeutics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ortek Therapeutics, 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?

  • NBLLight-Induced Fluorescence Caries Detector1decision
  • EJRAgent, Polishing, Abrasive, Oral Cavity1decision
  • LBHVarnish, Cavity1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K002989ProcludeOrtek Therapeutics, Inc. · 20003cite it
  • K003482Proclude-SensitiveOrtek Therapeutics, Inc. · 20011cites it

What has FDA decided for it lately?

  • K170822Electronic Caries DetectorOrtek Therapeutics, Inc. · 2017
  • K003482Proclude-SensitiveOrtek Therapeutics, Inc. · 2001
  • K002989ProcludeOrtek Therapeutics, Inc. · 2000

All 3 as Ortek Therapeutics, Inc. →