510(k) K061351
- Device
- ORAL-B SONIC COMPLETE
- Applicant
- BRAUN GMBH
- 510(k) number
- K061351
- Product code
- JEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-05
- Date received
- 2006-05-15
- 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
- AMANDA HEFFERNAN
- Address
- 800 Boylston St. Prudential Tower Bldg. Floor 46 Boston MA US 02199 02199
FDA Registration Numbers#
- 3006531065
- 1051614
- 3009220523
- 8043323
- 3007663061
- 3010872518
- 3042165668
- 3008346752
- 3033858988
- 3042278573
- 3014701704
- 3006552587
- 3035374295
- 3024512680
- 3020311844
- 3042262535
- 3015140245
- 3011171738
- 9616868
- 3030501507
- 3035857167
- 3009488700
- 9615008
- 3018123168
- 3015989868
- 3017685521
- 3010297540
- 3013524663
- 3014330970
- 3011210633
- 3013801623
- 3016660845
- 3027341447
- 3012118920
- 3042158862
- 3042278984
- 3032193293
- 3010162782
- 3028172072
- 3017376191
- 3013559599
- 3041928150
- 3023341286
- 3017816623
- 3016872092
- 3027315350
- 3007060769
- 3009926836
- 9710575
- 2240785
- 3017499498
- 3004069780
- 3024088964
- 3011839159
- 3012117640
- 3014561131
- 9710021
- 3014314529
- 3018418236
- 1067084
- 3009171220
- 3005781611
- 2511556
- 3013519273
- 3029507159
- 3009155756
- 3019887520
- 3008346978
- 3013445151
- 3027555933
- 3014579161
- 3045927242
- 3015526174
- 3042277637
- 3018975080
- 3011074933
- 3014437893
- 3006536571
- 3007420876
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 |
| 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 |
| K935150 | SONIPLAK | American Dentronics, Inc. | 1994-05-18 |
Legacy Summary#
summary
FDA Review#
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