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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K203567
Device Name Oral-B Dry Mouth Oral Rinse
Applicant
The Procter & Gamble Company
1 Procter & Gamble Plz.
Cincinnati,  OH  45202
Applicant Contact Brenda S. Fuentes
Correspondent
The Procter & Gamble Company
1 Procter & Gamble Plz.
Cincinnati,  OH  45202
Correspondent Contact Brenda S. Fuentes
Classification Product Code
LFD  
Date Received12/07/2020
Decision Date 04/05/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Clinical Trials NCT04189081
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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