Cleared Traditional

Oral-B iO Test Drive Power Brush Trial Program Kit

K200881 · The Procter & Gamble Company · Dental
Aug 2020
Decision
147d
Days
Class 1
Risk

About This 510(k) Submission

K200881 is an FDA 510(k) clearance for the Oral-B iO Test Drive Power Brush Trial Program Kit, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by The Procter & Gamble Company (Cincinnati, US). The FDA issued a Cleared decision on August 27, 2020, 147 days after receiving the submission on April 2, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.

Submission Details

510(k) Number K200881 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2020
Decision Date August 27, 2020
Days to Decision 147 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEQ — Toothbrush, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6865

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