Toothbrush, Powered
FDA product code JEQ · Class I (low risk) · 21 CFR 872.6865 · Dental
54510(k) clearances
0PMA approvals
15recalls
Manufacturers
- American Dentronics, Inc. 3
- Bausch & Lomb, Inc. 2
- Omron Healthcare, Inc. 2
- Procter & Gamble Co. 2
- John O. Butler Co. 2
- Braun GmbH 2
- Rgm Assoc. 1
- Windmere Corp. 1
- Home Dental Care, Inc. 1
- Pro-Dentec 1
- Lap Investments, Inc. 1
- Woog Intl. 1
- Xouth, Inc. 1
- Scherer Laboratories, Inc. 1
- Northern Electric Co. Div. of Sunbeam Corp. 1
- Mcspadden, Inc. 1
- Peter Martin Associates, Inc. 1
- Teledyne, Inc. 1
- Gilette Medical Eval. Laboratory 1
- Sunbeam Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200881 | Oral-B iO Test Drive Power Brush Trial Program KitJEQ · Traditional | The Procter & Gamble Company | 08/27/2020SE |
| K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…JEQ · Traditional | Procter & Gamble Co. | 09/15/2014SE |
| K061351 | Oral-B Sonic CompleteJEQ · Traditional | Braun GmbH | 06/05/2006SE |
| K061199 | Oral B Professionalcare Series, Oral B Advancepower SeriesJEQ · Traditional | Braun GmbH | 05/31/2006SE |
| K040416 | Sonicare Advance Toothbrush, Model 4900JEQ · Traditional | Philips Oral Healthcare, Inc. | 07/02/2004SE |
| K022900 | Butler Gum Vari-Clean Power ToothbrushesJEQ · Traditional | John O. Butler Co. | 11/14/2002SE |
| K012914 | Sonicwave Sonic Plaque RemoverJEQ · Traditional | Homedics, Inc. | 10/01/2001SE |
| K970381 | Powered ToothbrushJEQ · Traditional | Emjoi Action USA, Ltd. | 04/18/1997SE |
| K943942 | Trav-Ler KitJEQ · Traditional | John O. Butler Co. | 03/08/1995SESK |
| K945248 | Hukuba Hyg Electric Ionic ToothbrushJEQ · Traditional | Hukuba Dental Corp. | 01/26/1995SE |
| K944084 | Jeneric/Pentron P0WERED ToothbrustJEQ · Traditional | Jeneric/Pentron, Inc. | 12/20/1994SE |
| K942634 | PembushJEQ · Traditional | Crossroads Trading Co. | 09/02/1994SE |
| K941209 | My Beat Powered ToothbrushJEQ · Traditional | Sanwa Components USA, Inc. | 06/16/1994SE |
| K941243 | Oralspring Plus Battery-Powered ToothbrushJEQ · Traditional | Oraline, Ltd. | 06/06/1994SE |
| K940288 | Water Pik Sensonic Plaque Removal InstrumentJEQ · Traditional | Teledyne Water Pik | 05/26/1994SE |
| K935150 | SoniplakJEQ · Traditional | American Dentronics, Inc. | 05/18/1994SE |
| K935149 | SonibrushJEQ · Traditional | American Dentronics, Inc. | 01/31/1994SE |
| K935148 | SoniflossJEQ · Traditional | American Dentronics, Inc. | 01/31/1994SE |
| K936076 | Oral Ease Automatic Flosser/Power BrushJEQ · Traditional | Ohio Health Care Products, Inc. | 01/26/1994SE |
| K935561 | Interplak Home Plaque Removal InstrumentJEQ · Traditional | Bausch & Lomb, Inc. | 01/26/1994SE |
| K933829 | Pulse Electric ToothbrushJEQ · Traditional | Dentatech Corp. | 12/13/1993SE |
| K931360 | Electric Tooth-BrushJEQ · Traditional | U.S. Dentek Corp. | 07/13/1993SE |
| K926247 | Omron Travel Toothbrush/Plaque Remover #HT-B005JEQ · Traditional | Omron Healthcare, Inc. | 04/14/1993SE |
| K926246 | Omron Rechargeable Plaque Removal System #HT-B142JEQ · Traditional | Omron Healthcare, Inc. | 04/14/1993SE |
| K913724 | Sonex Ultrasonic Tooth BrushJEQ · Traditional | Sonex Intl., Corp. | 12/28/1992SE |
| K924739 | The Dentist's Tooth PolisherJEQ · Traditional | Ranir/Dcp Corp. | 11/24/1992SE |
| K921773 | TX Electric ToothbrushJEQ · Traditional | Optiva Corp. | 07/13/1992SE |
| K920644 | F499 Deluxe Electric Tooth Brush W/ StandJEQ · Traditional | Fairform Mfg., Co., Ltd. | 05/29/1992SE |
| K914198 | Power Floss and Brush Ew 129 & Ew 120JEQ · Traditional | Matsushita Electric Co. | 12/18/1991SE |
| K910610 | Interplak Home Plaque Removal InstrumentJEQ · Traditional | Bausch & Lomb, Inc. | 07/09/1991SE |
| K903488 | Meridien Dental SystemsJEQ · Traditional | Anco Merchandise Co., Ltd. | 07/09/1991SE |
| K904401 | Battery-Powered ToothbrushJEQ · Traditional | The B & F System, Inc. | 12/07/1990SE |
| K903510 | Mickey/Minnie Mouse Batt. Operate ToothbrushJEQ · Traditional | Helm Toy Corp. | 09/10/1990SE |
| K901963 | Omron Travel Toothbrush, Model HT-B02JEQ · Traditional | Omron Marshall Products, Inc. | 06/26/1990SE |
| K900766 | Epi Dent ToothbrushJEQ · Traditional | Epi Mfg. | 05/15/1990SE |
| K896245 | Plak Trac Powered ToothbrushJEQ · Traditional | Windmere Corp. | 03/28/1990SE |
| K893736 | Hot BrushJEQ · Traditional | Home Dental Care, Inc. | 02/14/1990SE |
| K891694 | The Smile MachineJEQ · Traditional | Brilliant Industries, Inc. | 06/16/1989SE |
| K880589 | Rota-Dent Tooth CleanerJEQ · Traditional | Pro-Dentec | 05/11/1988SE |
| K871929 | Probright Tooth PolisherJEQ · Traditional | Lap Investments, Inc. | 07/31/1987SE |
| K871406 | The Woog OrabrushJEQ · Traditional | Woog Intl. | 07/07/1987SE |
| K862224 | The Woog and the Woog D. Powered ToothbrushesJEQ · Traditional | Xouth, Inc. | 09/26/1986SE |
| K860264 | Scherer Portable Tooth PolisherJEQ · Traditional | Scherer Laboratories, Inc. | 06/26/1986SE |
| K854326 | No Floss FlosserJEQ · Traditional | Rgm Assoc. | 04/23/1986SE |
| K852476 | InterplakJEQ · Traditional | Dental Research Corp. | 07/31/1985SE |
| K852279 | Sunbeam Rechargeable Toothbrush Model # 4201JEQ · Traditional | Northern Electric Co. Div. of Sunbeam Corp. | 07/01/1985SE |
| K850562 | Flossage - Electric ToothflosserJEQ · Traditional | Mcspadden, Inc. | 03/27/1985SE |
| K820537 | Ultrasonic ToothbrushJEQ · Traditional | Ultrasonic Plaque Control Laboratories | 04/27/1982SE |
| K820503 | Svensk TK/2JEQ · Traditional | Peter Martin Associates, Inc. | 03/19/1982SE |
| K810805 | Water Pik Automatic ToothbrushJEQ · Traditional | Teledyne, Inc. | 04/14/1981SE |
| K810666 | Braun TravelJEQ · Traditional | Gilette Medical Eval. Laboratory | 04/14/1981SE |
| K780360 | Massager, Gum/Ssage Powered GumJEQ · Traditional | Sunbeam Corp. | 05/26/1978SE |
| K770997 | Pro-CareJEQ · Traditional | Young Dental Manufacturing Co. 1, LLC | 06/20/1977SE |
| K770116 | Porta-Pro Tooth PolisherJEQ · Traditional | Porta-Pro, Inc. | 01/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2734-2026 Class II | Papablic Replacement Brush Heads. Model Number: PAPA317AA.Potential for brush heads to break. | Papablic Inc | 05/21/2026Open, Classified |
| Z-2733-2026 Class II | Papablic Replacement Brush Heads. Model Number: Papablic18BPotential for brush heads to break. | Papablic Inc | 05/21/2026Open, Classified |
| Z-0782-2014 Class II | UP & UP kids' power toothbrushRanir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Clifford Kids… | Ranir Corporation | 12/18/2013Terminated |
| Z-0781-2014 Class II | TopCare Clifford THE BIG RED DOG power toothbrush for kids!Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Clifford Kids… | Ranir Corporation | 12/18/2013Terminated |
| Z-2099-2012 Class II | Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-2098-2012 Class II | Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-2097-2012 Class II | Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-2096-2012 Class II | Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-2095-2012 Class II | Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China.…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-2094-2012 Class II | Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China.…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-2093-2012 Class II | Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-0859-2012 Class II | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-0858-2012 Class II | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-0857-2012 Class II | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made…Church and Dwight plans to take actions to best convey to the public the potential small parts choking… | Church & Dwight Inc | 12/22/2011Terminated |
| Z-1724-2011 | W Vital Health Pulsating Clean Rechargeable Toothbrush; Distributed by: Walgreen Co.…The power toothbrush may make a loud noise and the battery cap becomes separated from the main body of the… | Brushpoint Innovations, Inc. | 01/14/2011Terminated |