510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K171542Substantially Equivalent

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges

Dr. Harold Katz, LLC (dba Therabreath, Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171542 is the FDA 510(k) clearance record for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges, cleared for Dr. Harold Katz, LLC (Dba Therabreath on under FDA product code LFD (Saliva, Artificial). FDA records list one 510(k) clearance for Dr. Harold Katz, LLC (Dba Therabreath. As of , FDA records show no recalls naming K171542.

Clearance record

Decision date
Received
(294 days to decision)
Product code
LFD Saliva, Artificial
Device class
Unclassified
Review panel
Unknown
Applicant
Dr. Harold Katz, LLC (Dba Therabreath 5802 Willoughby Ave., Los Angeles CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFD

Trailing 12 months
1 clearance under product code LFD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260