FDA 510(k) Applications for Medical Device Product Code "JEQ"
(Toothbrush, Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K935149 AMERICAN DENTRONICS, INC. SONIBRUSH 01/31/1994
K935148 AMERICAN DENTRONICS, INC. SONIFLOSS 01/31/1994
K935150 AMERICAN DENTRONICS, INC. SONIPLAK 05/18/1994
K903488 ANCO MERCHANDISE CO., LTD. MERIDIEN DENTAL SYSTEMS 07/09/1991
K910610 BAUSCH & LOMB, INC. INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT 07/09/1991
K935561 BAUSCH & LOMB, INC. INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT 01/26/1994
K061199 BRAUN GMBH ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES 05/31/2006
K061351 BRAUN GMBH ORAL-B SONIC COMPLETE 06/05/2006
K891694 BRILLIANT INDUSTRIES, INC. THE SMILE MACHINE 06/16/1989
K942634 CROSSROADS TRADING CO. PEMBUSH 09/02/1994
K852476 DENTAL RESEARCH CORP. INTERPLAK 07/31/1985
K933829 DENTATECH CORP. PULSE ELECTRIC TOOTHBRUSH 12/13/1993
K970381 EMJOI ACTION USA, LTD. POWERED TOOTHBRUSH 04/18/1997
K900766 EPI MFG. EPI DENT TOOTHBRUSH 05/15/1990
K920644 FAIRFORM MFG., CO., LTD. F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND 05/29/1992
K810666 GILETTE MEDICAL EVAL. LABORATORY BRAUN TRAVEL 04/14/1981
K903510 HELM TOY CORP. MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH 09/10/1990
K893736 HOME DENTAL CARE, INC. HOT BRUSH 02/14/1990
K012914 HOMEDICS, INC. SONICWAVE SONIC PLAQUE REMOVER 10/01/2001
K945248 HUKUBA DENTAL CORP. HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH 01/26/1995
K944084 JENERIC/PENTRON, INC. JENERIC/PENTRON P0WERED TOOTHBRUST 12/20/1994
K022900 JOHN O. BUTLER CO. BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES 11/14/2002
K943942 JOHN O. BUTLER CO. TRAV-LER KIT 03/08/1995
K871929 LAP INVESTMENTS, INC. PROBRIGHT TOOTH POLISHER 07/31/1987
K914198 MATSUSHITA ELECTRIC CO. POWER FLOSS AND BRUSH EW 129 & EW 120 12/18/1991
K850562 MCSPADDEN, INC. FLOSSAGE - ELECTRIC TOOTHFLOSSER 03/27/1985
K852279 NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP. SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 07/01/1985
K936076 OHIO HEALTH CARE PRODUCTS, INC. ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH 01/26/1994
K926246 OMRON HEALTHCARE, INC. OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142 04/14/1993
K926247 OMRON HEALTHCARE, INC. OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005 04/14/1993
K901963 OMRON MARSHALL PRODUCTS, INC. OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02 06/26/1990
K921773 OPTIVA CORP. TX ELECTRIC TOOTHBRUSH 07/13/1992
K941243 ORALINE, LTD. ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH 06/06/1994
K820503 PETER MARTIN ASSOCIATES, INC. SVENSK TK/2 03/19/1982
K040416 PHILIPS ORAL HEALTHCARE, INC. SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 07/02/2004
K770116 PORTA-PRO, INC. PORTA-PRO TOOTH POLISHER 01/28/1977
K880589 PRO-DENTEC ROTA-DENT TOOTH CLEANER 05/11/1988
K141018 PROCTER & GAMBLE CO. ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT 09/15/2014
K924739 RANIR/DCP CORP. THE DENTIST'S TOOTH POLISHER 11/24/1992
K854326 RGM ASSOC. NO FLOSS FLOSSER 04/23/1986
K941209 SANWA COMPONENTS USA, INC. MY BEAT POWERED TOOTHBRUSH 06/16/1994
K860264 SCHERER LABORATORIES, INC. SCHERER PORTABLE TOOTH POLISHER 06/26/1986
K913724 SONEX INTL., CORP. SONEX ULTRASONIC TOOTH BRUSH 12/28/1992
K780360 SUNBEAM CORP. MASSAGER, GUM/SSAGE POWERED GUM 05/26/1978
K940288 TELEDYNE WATER PIK WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT 05/26/1994
K810805 TELEDYNE, INC. WATER PIK AUTOMATIC TOOTHBRUSH 04/14/1981
K904401 THE B & F SYSTEM, INC. BATTERY-POWERED TOOTHBRUSH 12/07/1990
K931360 U.S. DENTEK CORP. ELECTRIC TOOTH-BRUSH 07/13/1993
K820537 ULTRASONIC PLAQUE CONTROL LABORATORIES ULTRASONIC TOOTHBRUSH 04/27/1982
K896245 WINDMERE CORP. PLAK TRAC "POWERED TOOTHBRUSH" 03/28/1990
K871406 WOOG INTL. THE WOOG ORABRUSH 07/07/1987
K862224 XOUTH, INC. THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES 09/26/1986
K770997 YOUNG DENTAL MANUFACTURING CO 1, LLC. PRO-CARE 06/20/1977


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