Cleared Traditional

ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES

K061199 · Braun GmbH · Dental
May 2006
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K061199 is an FDA 510(k) clearance for the ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by Braun GmbH (Boston, US). The FDA issued a Cleared decision on May 31, 2006, 33 days after receiving the submission on April 28, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.

Submission Details

510(k) Number K061199 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2006
Decision Date May 31, 2006
Days to Decision 33 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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