510(k) K943942
- Device
- TRAV-LER KIT
- Applicant
- JOHN O. BUTLER CO.
- 510(k) number
- K943942
- Product code
- JEQ
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 1995-03-08
- Date received
- 1994-08-12
- Regulation
- 872.6865
- Classification name
- Toothbrush, Powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT KOEPSEL
- Address
- 4635 W Foster Ave. Chicago IL US 60630 60630
FDA Registration Numbers#
- 3008366788
- 3016815802
- 3024512680
- 3044744766
- 3039304811
- 3004623350
- 3004305946
- 3010864832
- 3016660845
- 3008346978
- 3008346752
- 3006795917
- 3007060769
- 3014468707
- 3010419931
- 3016904853
- 3043476844
- 3008103948
- 3015527463
- 3027320022
- 3013600135
- 3016445768
- 3015282707
- 3015136935
- 3014437893
- 9615428
- 3020393302
- 3004102812
- 3017177487
- 3006629593
- 3016872092
- 3012041047
- 3014264827
- 1413787
- 3017178443
- 3017887928
- 3016170496
- 3014110830
- 3038195230
- 9616868
- 3041928150
- 3011077581
- 3017618900
- 3043088172
- 3013120141
- 3023222182
- 3006536571
- 3020145267
- 3006982887
- 3012421607
- 3006532271
- 3033905868
- 3035732161
- 3013521677
- 3017499498
- 3012896103
- 3014561131
- 3019912897
- 8043323
- 3021245739
- 3007838093
- 3022553912
- 3012833978
- 3018123168
- 3030671618
- 3042278984
- 3010262284
- 3008344782
- 3005781611
- 2280705
- 3004529379
- 3042158862
- 3030795695
- 3017954358
- 3011964664
- 3000302531
- 3008648418
- 3024999438
- 3007601164
Source Documents#
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 |
| 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