510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K143155Substantially Equivalent

LISTERINE Sensitivity Defense Mouthrinse

Johnson & Johnson Healthcare Products, Division of Mcneil-Pp, Skillman NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143155 is the FDA 510(k) clearance record for LISTERINE Sensitivity Defense Mouthrinse, a class II device, cleared for Johnson & Johnson Healthcare Products, Division of Mcneil-Pp on under FDA product code LBH (Varnish, Cavity). FDA records list one 510(k) clearance for Johnson & Johnson Healthcare Products, Division of Mcneil-Pp. As of , FDA records show no recalls naming K143155.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Johnson & Johnson Healthcare Products, Division of Mcneil-Pp 199 Grandview Rd., Skillman NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBH

Trailing 12 months
6 clearances under product code LBH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260