510(k) K022900
- Device
- BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
- Applicant
- JOHN O. BUTLER CO.
- 510(k) number
- K022900
- Product code
- JEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-14
- Date received
- 2002-09-03
- 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
- KEVIN G YOST
- Address
- 4635 W Foster Ave. Chicago IL US 60630 60630
FDA Registration Numbers#
- 3015140245
- 3026025701
- 3017954358
- 3011180741
- 3033858988
- 3008960188
- 3007663061
- 3013662621
- 3010262284
- 3021422553
- 3014290918
- 3011171738
- 3010047475
- 3007502533
- 3024555465
- 3004201548
- 3004102812
- 3009220523
- 3018123168
- 3033905868
- 1836348
- 3025428426
- 3030795695
- 3004270595
- 3014330970
- 3007420876
- 3003799843
- 3013445151
- 3035857167
- 3010701675
- 3015925939
- 3007060769
- 2218158
- 3011644607
- 3004529379
- 3011210633
- 3010382415
- 3015698523
- 3013557562
- 3014701704
- 3003630806
- 1417592
- 3013257234
- 3016170496
- 3012041047
- 3010730876
- 3020145267
- 3009926836
- 3013972866
- 3004305946
- 3026182452
- 3015217632
- 3016872092
- 3017248108
- 3014468707
- 3015526174
- 3026753375
- 3018783126
- 9615428
- 3011074933
- 3026282195
- 3010864832
- 3008346752
- 3013181914
- 3008648418
- 3042278573
- 3017208137
- 3017555752
- 3002485596
- 3015287618
- 3016241126
- 1067084
- 3005816808
- 3003889521
- 3016427447
- 3007113231
- 3027320022
- 3010036307
- 3011839159
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 |
| 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 |
| K935150 | SONIPLAK | American Dentronics, Inc. | 1994-05-18 |
Legacy Summary#
summary
FDA Review#
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