Cleared Traditional

ORAL-B SONIC COMPLETE

K061351 · Braun GmbH · Dental
Jun 2006
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K061351 is an FDA 510(k) clearance for the ORAL-B SONIC COMPLETE, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by Braun GmbH (Boston, US). The FDA issued a Cleared decision on June 5, 2006, 21 days after receiving the submission on May 15, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.

Submission Details

510(k) Number K061351 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2006
Decision Date June 05, 2006
Days to Decision 21 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

Similar Devices — JEQ Toothbrush, Powered

All 53
Oral-B iO Test Drive Power Brush Trial Program Kit
K200881 · The Procter & Gamble Company · Aug 2020
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
K141018 · Procter & Gamble Co. · Sep 2014
ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
K061199 · Braun GmbH · May 2006
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
K040416 · Philips Oral Healthcare, Inc. · Jul 2004
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
K022900 · John O. Butler Co. · Nov 2002
SONICWAVE SONIC PLAQUE REMOVER
K012914 · Homedics, Inc. · Oct 2001