510(k) K926247
- Device
- OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
- Applicant
- OMRON HEALTHCARE, INC.
- 510(k) number
- K926247
- Product code
- JEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-04-14
- Date received
- 1992-12-14
- Regulation
- 872.6865
- Classification name
- Toothbrush, Powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANK BRICHETTO
- Address
- 300 Lakeview Pkwy. Vernon Hills IL US 60061 60061
FDA Registration Numbers#
- 3015282468
- 3011524638
- 3017954358
- 3010683450
- 3004529379
- 3016427447
- 3015337428
- 3007502533
- 3017178443
- 3013185096
- 3015456958
- 3009124884
- 2381321
- 3015965671
- 3021031939
- 3000268902
- 8043847
- 9615428
- 3034278341
- 9680012
- 2245519
- 3042262535
- 3042278984
- 3016818428
- 3017911304
- 3017538926
- 3042256682
- 3030192581
- 3008343409
- 3017555752
- 3030795695
- 3014264827
- 3005980667
- 3043883115
- 3020145267
- 3018975080
- 3009155756
- 3001149827
- 3021624342
- 3008328678
- 3014314529
- 3017177487
- 3033858988
- 3017195494
- 3026164517
- 3008648418
- 3011210633
- 3011180741
- 3013579894
- 1910469
- 3014610038
- 1413787
- 3014527840
- 3016458459
- 3027555933
- 3015527463
- 3014707731
- 3013735167
- 3012833978
- 3010262284
- 3012133441
- 3000099306
- 3019804885
- 3017610929
- 3007238544
- 3020311844
- 3010047475
- 3015925939
- 3035731494
- 3013557562
- 3029952413
- 1000634183
- 3007663061
- 3030671618
- 3010864832
- 3030089889
- 3017406171
- 3042277637
- 3013561919
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#
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
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