Product Code: JEQ
FDA class 1
21 CFR 872.6865
Toothbrush, Powered
Dental
A Powered Toothbrush is an electrically or battery-operated dental hygiene device used by patients to remove plaque and maintain oral health through mechanical brushing action. It is classified as FDA Class 1 (lowest risk), subject only to general controls including proper labeling and device registration. The product code is JEQ, regulated under 21 CFR 872.6865, within the Dental medical specialty. No special flags apply to this device.
510(k)s
54
FEI Numbers
358
Registration Numbers
359
Unique Applicants
48
Years Active
44
Basic Information
- Product Code
- JEQ
- Device Class
- FDA class 1
- Regulation Number
- 872.6865
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 54 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | Aug 27, 2020 | Substantially Equivalent | The Procter & Gamble Company |
| K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | Sep 15, 2014 | Substantially Equivalent | PROCTER & GAMBLE CO. |
| K061351 | ORAL-B SONIC COMPLETE | Jun 05, 2006 | Substantially Equivalent | BRAUN GMBH |
| K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | May 31, 2006 | Substantially Equivalent | BRAUN GMBH |
| K040416 | SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 | Jul 02, 2004 | Substantially Equivalent | PHILIPS ORAL HEALTHCARE, INC. |
| K022900 | BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES | Nov 14, 2002 | Substantially Equivalent | JOHN O. BUTLER CO. |
| K012914 | SONICWAVE SONIC PLAQUE REMOVER | Oct 01, 2001 | Substantially Equivalent | HOMEDICS, INC. |
| K970381 | POWERED TOOTHBRUSH | Apr 18, 1997 | Substantially Equivalent | EMJOI ACTION USA, LTD. |
| K943942 | TRAV-LER KIT | Mar 08, 1995 | Unknown | JOHN O. BUTLER CO. |
| K945248 | HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH | Jan 26, 1995 | Substantially Equivalent | HUKUBA DENTAL CORP. |
| K944084 | JENERIC/PENTRON P0WERED TOOTHBRUST | Dec 20, 1994 | Substantially Equivalent | JENERIC/PENTRON, INC. |
| K942634 | PEMBUSH | Sep 02, 1994 | Substantially Equivalent | CROSSROADS TRADING CO. |
| K941209 | MY BEAT POWERED TOOTHBRUSH | Jun 16, 1994 | Substantially Equivalent | SANWA COMPONENTS USA, INC. |
| K941243 | ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH | Jun 06, 1994 | Substantially Equivalent | ORALINE, LTD. |
| K940288 | WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT | May 26, 1994 | Substantially Equivalent | TELEDYNE WATER PIK |
| K935150 | SONIPLAK | May 18, 1994 | Substantially Equivalent | AMERICAN DENTRONICS, INC. |
| K935149 | SONIBRUSH | Jan 31, 1994 | Substantially Equivalent | AMERICAN DENTRONICS, INC. |
| K935148 | SONIFLOSS | Jan 31, 1994 | Substantially Equivalent | AMERICAN DENTRONICS, INC. |
| K936076 | ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH | Jan 26, 1994 | Substantially Equivalent | OHIO HEALTH CARE PRODUCTS, INC. |
| K935561 | INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT | Jan 26, 1994 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K933829 | PULSE ELECTRIC TOOTHBRUSH | Dec 13, 1993 | Substantially Equivalent | DENTATECH CORP. |
| K931360 | ELECTRIC TOOTH-BRUSH | Jul 13, 1993 | Substantially Equivalent | U.S. DENTEK CORP. |
| K926247 | OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005 | Apr 14, 1993 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K926246 | OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142 | Apr 14, 1993 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K913724 | SONEX ULTRASONIC TOOTH BRUSH | Dec 28, 1992 | Substantially Equivalent | SONEX INTL., CORP. |
| K924739 | THE DENTIST'S TOOTH POLISHER | Nov 24, 1992 | Substantially Equivalent | RANIR/DCP CORP. |
| K921773 | TX ELECTRIC TOOTHBRUSH | Jul 13, 1992 | Substantially Equivalent | OPTIVA CORP. |
| K920644 | F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND | May 29, 1992 | Substantially Equivalent | FAIRFORM MFG., CO., LTD. |
| K914198 | POWER FLOSS AND BRUSH EW 129 & EW 120 | Dec 18, 1991 | Substantially Equivalent | MATSUSHITA ELECTRIC CO. |
| K910610 | INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT | Jul 09, 1991 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K903488 | MERIDIEN DENTAL SYSTEMS | Jul 09, 1991 | Substantially Equivalent | ANCO MERCHANDISE CO., LTD. |
| K904401 | BATTERY-POWERED TOOTHBRUSH | Dec 07, 1990 | Substantially Equivalent | THE B & F SYSTEM, INC. |
| K903510 | MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH | Sep 10, 1990 | Substantially Equivalent | HELM TOY CORP. |
| K901963 | OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02 | Jun 26, 1990 | Substantially Equivalent | OMRON MARSHALL PRODUCTS, INC. |
| K900766 | EPI DENT TOOTHBRUSH | May 15, 1990 | Substantially Equivalent | EPI MFG. |
| K896245 | PLAK TRAC POWERED TOOTHBRUSH | Mar 28, 1990 | Substantially Equivalent | WINDMERE CORP. |
| K893736 | HOT BRUSH | Feb 14, 1990 | Substantially Equivalent | HOME DENTAL CARE, INC. |
| K891694 | THE SMILE MACHINE | Jun 16, 1989 | Substantially Equivalent | BRILLIANT INDUSTRIES, INC. |
| K880589 | ROTA-DENT TOOTH CLEANER | May 11, 1988 | Substantially Equivalent | PRO-DENTEC |
| K871929 | PROBRIGHT TOOTH POLISHER | Jul 31, 1987 | Substantially Equivalent | LAP INVESTMENTS, INC. |
| K871406 | THE WOOG ORABRUSH | Jul 07, 1987 | Substantially Equivalent | WOOG INTL. |
| K862224 | THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES | Sep 26, 1986 | Substantially Equivalent | XOUTH, INC. |
| K860264 | SCHERER PORTABLE TOOTH POLISHER | Jun 26, 1986 | Substantially Equivalent | SCHERER LABORATORIES, INC. |
| K854326 | NO FLOSS FLOSSER | Apr 23, 1986 | Substantially Equivalent | RGM ASSOC. |
| K852476 | INTERPLAK | Jul 31, 1985 | Substantially Equivalent | DENTAL RESEARCH CORP. |
| K852279 | SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 | Jul 01, 1985 | Substantially Equivalent | NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP. |
| K850562 | FLOSSAGE - ELECTRIC TOOTHFLOSSER | Mar 27, 1985 | Substantially Equivalent | MCSPADDEN, INC. |
| K820537 | ULTRASONIC TOOTHBRUSH | Apr 27, 1982 | Substantially Equivalent | ULTRASONIC PLAQUE CONTROL LABORATORIES |
| K820503 | SVENSK TK/2 | Mar 19, 1982 | Substantially Equivalent | PETER MARTIN ASSOCIATES, INC. |
| K810805 | WATER PIK AUTOMATIC TOOTHBRUSH | Apr 14, 1981 | Substantially Equivalent | TELEDYNE, INC. |
| K810666 | BRAUN TRAVEL | Apr 14, 1981 | Substantially Equivalent | GILETTE MEDICAL EVAL. LABORATORY |
| K780360 | MASSAGER, GUM/SSAGE POWERED GUM | May 26, 1978 | Substantially Equivalent | SUNBEAM CORP. |
| K770997 | PRO-CARE | Jun 20, 1977 | Substantially Equivalent | YOUNG DENTAL MANUFACTURING CO 1, LLC. |
| K770116 | PORTA-PRO TOOTH POLISHER | Jan 28, 1977 | Substantially Equivalent | PORTA-PRO, INC. |
FEI Numbers
This FDA classification entry is associated with 358 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 359 registration numbers. Click on an entry to view related FDA registrations.