JEQ · Toothbrush, Powered
Dental · 21 CFR 872.6865 · Class 1
Overview
| Product Code | JEQ |
|---|---|
| Device Name | Toothbrush, Powered |
| Regulation | 21 CFR 872.6865 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 54)
Showing 20 most recent of 54 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | The Procter & Gamble Company | Aug 27, 2020 | SESE |
| K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | Procter & Gamble Co. | Sep 15, 2014 | SESE |
| K061351 | ORAL-B SONIC COMPLETE | Braun GmbH | Jun 5, 2006 | SESE |
| K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | Braun GmbH | May 31, 2006 | SESE |
| K040416 | SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 | Philips Oral Healthcare, Inc. | Jul 2, 2004 | SESE |
| K022900 | BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES | John O. Butler Co. | Nov 14, 2002 | SESE |
| K012914 | SONICWAVE SONIC PLAQUE REMOVER | Homedics, Inc. | Oct 1, 2001 | SESE |
| K970381 | POWERED TOOTHBRUSH | Emjoi Action USA, Ltd. | Apr 18, 1997 | SESE |
| K943942 | TRAV-LER KIT | John O. Butler Co. | Mar 8, 1995 | SESK |
| K945248 | HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH | Hukuba Dental Corp. | Jan 26, 1995 | SESE |
| K944084 | JENERIC/PENTRON P0WERED TOOTHBRUST | Jeneric/Pentron, Inc. | Dec 20, 1994 | SESE |
| K942634 | PEMBUSH | Crossroads Trading Co. | Sep 2, 1994 | SESE |
| K941209 | MY BEAT POWERED TOOTHBRUSH | Sanwa Components USA, Inc. | Jun 16, 1994 | SESE |
| K941243 | ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH | Oraline, Ltd. | Jun 6, 1994 | SESE |
| K940288 | WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT | Teledyne Water Pik | May 26, 1994 | SESE |
| K935150 | SONIPLAK | American Dentronics, Inc. | May 18, 1994 | SESE |
| K935149 | SONIBRUSH | American Dentronics, Inc. | Jan 31, 1994 | SESE |
| K935148 | SONIFLOSS | American Dentronics, Inc. | Jan 31, 1994 | SESE |
| K936076 | ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH | Ohio Health Care Products, Inc. | Jan 26, 1994 | SESE |
| K935561 | INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT | Bausch & Lomb, Inc. | Jan 26, 1994 | SESE |
Top Applicants
- American Dentronics, Inc. — 3 clearances
- Bausch & Lomb, Inc. — 2 clearances
- Braun GmbH — 2 clearances
- John O. Butler Co. — 2 clearances
- Omron Healthcare, Inc. — 2 clearances
