Probright Tooth Polisher

FDA 510(k) K871929 · Lap Investments, Inc.

Substantially Equivalent

510(k) numberK871929

Submission

Device name
Probright Tooth Polisher
Applicant
Lap Investments, Inc.
Dallas, TX, US
Received
May 18, 1987
Decision date
July 31, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

510(k)DeviceApplicantDecision
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

Questions and answers

When was Probright Tooth Polisher cleared by the FDA?

Probright Tooth Polisher (K871929) received a 510(k) decision of Substantially Equivalent on July 31, 1987, 74 days after the submission was received.

What is the product code of K871929?

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