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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K143155
Device Name LISTERINE Sensitivity Defense Mouthrinse
Applicant
Johnson & Johnson Healthcare Products, Division of Mcneil-Pp
199 Grandview Rd.
Skillman,  NJ  08558
Applicant Contact ANGELINA M. HUNT
Correspondent
Johnson & Johnson Healthcare Products, Division of Mcneil-Pp
199 Grandview Rd.
Skillman,  NJ  08558
Correspondent Contact ANGELINA M. HUNT
Regulation Number872.3260
Classification Product Code
LBH  
Date Received11/03/2014
Decision Date 01/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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