510(k) K936076
- Device
- ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
- Applicant
- OHIO HEALTH CARE PRODUCTS, INC.
- 510(k) number
- K936076
- Product code
- JEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-26
- Date received
- 1993-12-20
- Regulation
- 872.6865
- Classification name
- Toothbrush, Powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN J COHEN
- Address
- 9024-C Euclid Ave. Manassas VA US 22110 22110
FDA Registration Numbers#
- 3007113231
- 3016076077
- 3017249486
- 2245519
- 3013735167
- 3018975080
- 3014468707
- 3039396072
- 3034731361
- 3017887928
- 3030089889
- 3000099306
- 3018258389
- 3010486573
- 3013428189
- 3043269767
- 3014437893
- 3017610929
- 3008346978
- 3007842535
- 3014579161
- 3029507159
- 3004154770
- 3010864832
- 3004201548
- 3043049068
- 1836348
- 2031532
- 3004134939
- 3026164517
- 3022553912
- 3011052946
- 3008345424
- 3010027944
- 3006982887
- 3010701675
- 3003630806
- 3024555465
- 2511556
- 3013120141
- 3026025701
- 3008770703
- 3003799843
- 3016872092
- 3017178443
- 3035857167
- 3030142290
- 3018123168
- 3015217632
- 3013521677
- 3012133441
- 3009515470
- 3013257234
- 3011524638
- 9615428
- 1051594
- 3013445151
- 3007502533
- 3014110830
- 3013801623
- 1910469
- 3015168527
- 3042165668
- 3014330970
- 3021012565
- 9680012
- 3043709874
- 1825660
- 3030501507
- 3017538926
- 3012499628
- 3013579894
- 3006552587
- 3006629593
- 3033858988
- 3017230595
- 3015456958
- 3038200340
- 3007770329
- 3010683450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JEQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | The Procter & Gamble Company | 2020-08-27 |
| 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. | 2014-09-15 |
| K061351 | ORAL-B SONIC COMPLETE | Braun GmbH | 2006-06-05 |
| K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | Braun GmbH | 2006-05-31 |
| K040416 | SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 | Philips Oral Healthcare, Inc. | 2004-07-02 |
| K022900 | BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES | John O. Butler Co. | 2002-11-14 |
| K012914 | SONICWAVE SONIC PLAQUE REMOVER | Homedics, Inc. | 2001-10-01 |
| K970381 | POWERED TOOTHBRUSH | Emjoi Action USA, Ltd. | 1997-04-18 |
| K943942 | TRAV-LER KIT | John O. Butler Co. | 1995-03-08 |
| K945248 | HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH | Hukuba Dental Corp. | 1995-01-26 |
| K944084 | JENERIC/PENTRON P0WERED TOOTHBRUST | Jeneric/Pentron, Inc. | 1994-12-20 |
| K942634 | PEMBUSH | Crossroads Trading Co. | 1994-09-02 |
| K941209 | MY BEAT POWERED TOOTHBRUSH | Sanwa Components USA, Inc. | 1994-06-16 |
| K941243 | ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH | Oraline, Ltd. | 1994-06-06 |
| K940288 | WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT | Teledyne Water Pik | 1994-05-26 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases