Cleared Traditional

Oral-B Dry Mouth Oral Rinse

K203567 · The Procter & Gamble Company · Dental
Apr 2021
Decision
119d
Days
—
Risk

About This 510(k) Submission

K203567 is an FDA 510(k) clearance for the Oral-B Dry Mouth Oral Rinse, a Saliva, Artificial, submitted by The Procter & Gamble Company (Cincinnati, US). The FDA issued a Cleared decision on April 5, 2021, 119 days after receiving the submission on December 7, 2020. This device falls under the Dental review panel.

Submission Details

510(k) Number K203567 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2020
Decision Date April 05, 2021
Days to Decision 119 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD — Saliva, Artificial
Device Class —

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