Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit, Oral-B Test Drive Refill Kit

FDA 510(k) K141018 · Procter & Gamble Co.

Substantially Equivalent

510(k) numberK141018

Submission

Device name
Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit, Oral-B Test Drive Refill Kit
Applicant
Procter & Gamble Co.
Mason, OH, US
Received
April 21, 2014
Decision date
September 15, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JEQ – Toothbrush, Powered
Device class
Class I (low risk)
Regulation
21 CFR 872.6865
Specialty
Dental

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K061199Oral B Professionalcare Series, Oral B Advancepower SeriesJEQ · Traditional Braun GmbH05/31/2006SE
K040416Sonicare Advance Toothbrush, Model 4900JEQ · Traditional Philips Oral Healthcare, Inc.07/02/2004SE
K022900Butler Gum Vari-Clean Power ToothbrushesJEQ · Traditional John O. Butler Co.11/14/2002SE
K012914Sonicwave Sonic Plaque RemoverJEQ · Traditional Homedics, Inc.10/01/2001SE
K970381Powered ToothbrushJEQ · Traditional Emjoi Action USA, Ltd.04/18/1997SE
K943942Trav-Ler KitJEQ · Traditional John O. Butler Co.03/08/1995SESK
K945248Hukuba Hyg Electric Ionic ToothbrushJEQ · Traditional Hukuba Dental Corp.01/26/1995SE
K944084Jeneric/Pentron P0WERED ToothbrustJEQ · Traditional Jeneric/Pentron, Inc.12/20/1994SE

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Questions and answers

When was Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit, Oral-B Test Drive Refill Kit cleared by the FDA?

Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit, Oral-B Test Drive Refill Kit (K141018) received a 510(k) decision of Substantially Equivalent on September 15, 2014, 147 days after the submission was received.

What is the product code of K141018?

The FDA product code is JEQ – Toothbrush, Powered, a Class I (low risk) device regulated under 21 CFR 872.6865.