TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges— 510(k) K171542

Name: FDA 510(k) clearance K171542
Creator: U.S. Food and Drug Administration
Published: 2018-03-16

Substantially Equivalent

Dr. Harold Katz, LLC (Dba Therabreath

FDA 510(k) clearance K171542 for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges, Substantially Equivalent on 2018-03-16. Applicant: Dr. Harold Katz, LLC (Dba Therabreath. Device class: Unclassified.

Clearance details

Applicant: Dr. Harold Katz, LLC (Dba Therabreath
Product code: Code LFD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2017-05-26
Decision date: 2018-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFD

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K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)2024-04-19
K234015 — Caphosol® Artifical Saliva (32 doses sachet box)2024-03-11
K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray2023-08-22

Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.