Cleared Traditional

K171542 - TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges (FDA 510(k) Clearance)

K171542 · Dr. Harold Katz, LLC (Dba Therabreath · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
294d
Days
-
Risk

K171542 is an FDA 510(k) clearance for the TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges. Classified as Saliva, Artificial (product code LFD).

Submitted by Dr. Harold Katz, LLC (Dba Therabreath (Los Angeles, US). The FDA issued a Cleared decision on March 16, 2018 after a review of 294 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dr. Harold Katz, LLC (Dba Therabreath devices

Submission Details

510(k) Number K171542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2017
Decision Date March 16, 2018
Days to Decision 294 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 127d · This submission: 294d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
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