Electric Tooth-Brush

FDA 510(k) K931360 · U.S. Dentek Corp.

Substantially Equivalent

510(k) numberK931360

Submission

Device name
Electric Tooth-Brush
Applicant
U.S. Dentek Corp.
Novato, CA, US
Received
March 17, 1993
Decision date
July 13, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
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

More from Hukuba Dental Corp.

510(k)DeviceDecision
K961574Tongue ScrapperLCN · Traditional 06/10/1996SE
K892861Dental PikEKS · Traditional 09/15/1989SE
K881046Super Pik Massaging Pick for Oral HygieneJET · Traditional 05/13/1988SE

Questions and answers

When was Electric Tooth-Brush cleared by the FDA?

Electric Tooth-Brush (K931360) received a 510(k) decision of Substantially Equivalent on July 13, 1993, 118 days after the submission was received.

What is the product code of K931360?

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