Butler Gum Vari-Clean Power Toothbrushes

FDA 510(k) K022900 · John O. Butler Co.

Substantially Equivalent

510(k) numberK022900

Submission

Device name
Butler Gum Vari-Clean Power Toothbrushes
Applicant
John O. Butler Co.
Chicago, IL, US
Received
September 3, 2002
Decision date
November 14, 2002
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

Other 510(k)s with product code JEQ

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K200881Oral-B iO Test Drive Power Brush Trial Program KitJEQ · Traditional The Procter & Gamble Company08/27/2020SE
K141018Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…JEQ · Traditional Procter & Gamble Co.09/15/2014SE
K061351Oral-B Sonic CompleteJEQ · Traditional Braun GmbH06/05/2006SE
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
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

More from Jeneric/Pentron, Inc.

510(k)DeviceDecision
K974761Butler Antibacterial Interdental ToothbrushEFW · Traditional 06/16/1998SE
K952091Vutler G.U.M. with FluorideJES · Traditional 06/28/1995SE
K950993Butler G.U.M. Antibacterial ToothbrushEFW · Traditional 06/02/1995SE
K943942Trav-Ler KitJEQ · Traditional 03/08/1995SESK
K874194Protect Drops/Same AS K874070EJK · Traditional 12/16/1987SE

Questions and answers

When was Butler Gum Vari-Clean Power Toothbrushes cleared by the FDA?

Butler Gum Vari-Clean Power Toothbrushes (K022900) received a 510(k) decision of Substantially Equivalent on November 14, 2002, 72 days after the submission was received.

What is the product code of K022900?

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