510(k) K896245
- Device
- PLAK TRAC POWERED TOOTHBRUSH
- Applicant
- WINDMERE CORP.
- 510(k) number
- K896245
- Product code
- JEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-28
- Date received
- 1989-10-30
- Regulation
- 872.6865
- Classification name
- Toothbrush, Powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J SOKOLOW
- Address
- 5980 Miami Lades Dr. Miami Lakes FL US 33014 33014
FDA Registration Numbers#
- 3007238544
- 3015217632
- 2018957
- 3042262535
- 3017230595
- 3007479587
- 3038319255
- 3001149827
- 3043049068
- 3042158862
- 3022553912
- 3042870861
- 3004134939
- 3006115534
- 3014290918
- 3016818428
- 3016241126
- 9614443
- 3009220523
- 3017816623
- 3005607112
- 3009488700
- 3013559599
- 1712259
- 3013428189
- 3035732161
- 3014314529
- 3026630
- 9615008
- 3011171738
- 3008138005
- 3030091541
- 3032193293
- 3015337428
- 3030142290
- 3008770703
- 3009450029
- 3027645138
- 3011180741
- 3027344647
- 3015698523
- 3018123168
- 3006552587
- 3020284548
- 3039396072
- 3004623350
- 3042278984
- 3033905868
- 3015527463
- 3024512680
- 3034731361
- 3017249486
- 3008346978
- 3007420876
- 3014707731
- 3027320022
- 3014701704
- 3011077581
- 3024555465
- 3009155756
- 3029952413
- 3016731115
- 3015456958
- 3010162782
- 3000302531
- 3018975080
- 3016076077
- 1222304
- 3027328721
- 3031293716
- 3000268902
- 3003799843
- 3012499628
- 3017610929
- 3012421607
- 3005816808
- 8043323
- 3007601164
- 3010382415
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