510(k) Report

FDA applicant

Dr. Harold Katz, LLC (Dba Therabreath

Los Angeles, CA1 decision2018–20180 recalls

FDA records 1 decision for Dr. Harold Katz, LLC (Dba Therabreath (Los Angeles, CA) in 2018: 1 510(k) clearance. All are in product code LFD (Saliva, Artificial). Its devices cite 2 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

How often FDA has decided Dr. Harold Katz, LLC (Dba Therabreath’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Dr. Harold Katz, LLC (Dba Therabreath by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dr. Harold Katz, LLC (Dba Therabreath’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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Which product codes does it file in?

  • LFDSaliva, Artificial1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath · 2018

The one decision as Dr. Harold Katz, LLC (Dba Therabreath →