510(k) K880589
- Device
- ROTA-DENT TOOTH CLEANER
- Applicant
- PRO-DENTEC
- 510(k) number
- K880589
- Product code
- JEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-05-11
- Date received
- 1988-02-11
- 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
- THOMAS J MULDOON
- Address
- 333 W. Wacker Dr. Suite 1900 Chicago IL US 60606 60606
FDA Registration Numbers#
- 3044174138
- 9680012
- 3017618922
- 3014290448
- 3014561131
- 3042158862
- 3008925277
- 3039398006
- 3022553912
- 3005980667
- 3016660845
- 3007238544
- 3013557562
- 3007711548
- 3043512617
- 3011654863
- 3017403359
- 3045927242
- 3004134939
- 3021368823
- 3016815802
- 3016445768
- 3007309332
- 3021031939
- 3042278984
- 1910469
- 3000099306
- 3013370843
- 3030541643
- 3033911545
- 3015050498
- 3008346978
- 3038373471
- 3010036307
- 3021245739
- 3029987245
- 3021422553
- 3011074933
- 3017406171
- 3012217421
- 3003491259
- 3011839159
- 3017685521
- 3010382415
- 9710575
- 3010262284
- 3042262535
- 3008366788
- 3015140245
- 3043269767
- 3043476844
- 3017265430
- 3042277637
- 3014110830
- 3013561919
- 3007663061
- 9615428
- 3015282707
- 3011052946
- 3013735167
- 1000634183
- 3021963363
- 3013972866
- 3035857167
- 3017248108
- 3011170521
- 3004201548
- 3014246581
- 3020145267
- 3026630
- 3027320022
- 3010822231
- 3030795695
- 3034048670
- 3008343409
- 3023395601
- 2031532
- 3007770329
- 3016241126
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