Oral-B Dry Mouth Oral Rinse

Saliva, Artificial

The Proctor & Gamble Company

The following data is part of a premarket notification filed by The Proctor & Gamble Company with the FDA for Oral-b Dry Mouth Oral Rinse.

Pre-market Notification Details

Device IDK201277
510k NumberK201277
Device Name:Oral-B Dry Mouth Oral Rinse
ClassificationSaliva, Artificial
Applicant The Proctor & Gamble Company 1 Proctor & Gamble Plaza Cincinnati,  OH  45202
ContactMichael A Kaminski
CorrespondentMichael A Kaminski
The Proctor & Gamble Company 8700 Mason Montgomery Road Mason,  OH  45040
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-13
Decision Date2020-09-02

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