510(k) K970381
- Device
- POWERED TOOTHBRUSH
- Applicant
- EMJOI ACTION USA, LTD.
- 510(k) number
- K970381
- Product code
- JEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-18
- Date received
- 1997-02-03
- 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
- JAMES R MARSHALL, PH.D.
- Address
- 7-B Old Colony Dr. Westford MA US 01886 01886
FDA Registration Numbers#
- 3030671618
- 3015825358
- 3013257234
- 3006532271
- 3013559599
- 3014266447
- 3010486573
- 3010864832
- 3010419931
- 8043323
- 3010872518
- 3038195230
- 3010027944
- 3014268398
- 3007842535
- 3006982887
- 3011171738
- 3030091541
- 3021245739
- 3020393302
- 3013524663
- 3006629593
- 3011180741
- 3005607635
- 3017618900
- 3003491259
- 3006795917
- 1051594
- 3016170496
- 3035880570
- 3014264827
- 3013120141
- 3012803257
- 3043709874
- 3005607112
- 3004201548
- 1825660
- 3027315350
- 3017911304
- 3016445768
- 3042165668
- 3015220912
- 3022553912
- 3032193293
- 3042256682
- 3014489880
- 3020145267
- 3007309332
- 3014437893
- 3013185096
- 3008346978
- 9615428
- 3011077581
- 3018975080
- 3021368823
- 3011210633
- 3010162782
- 3035577695
- 3014290918
- 3042158862
- 3013519273
- 3021963363
- 3010382415
- 3015140245
- 3015925939
- 3008960188
- 3011052946
- 3014707731
- 3044744766
- 3004529379
- 3004134939
- 3007060769
- 3013445151
- 3014314529
- 3035732161
- 3009515470
- 3003630806
- 3026282195
- 3017403359
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 |
| 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 |
| K935150 | SONIPLAK | American Dentronics, Inc. | 1994-05-18 |
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