510(k) K780360
- Device
- MASSAGER, GUM/SSAGE POWERED GUM
- Applicant
- SUNBEAM CORP.
- 510(k) number
- K780360
- Product code
- JEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-26
- Date received
- 1978-03-06
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008293988
- 3023222182
- 3020311844
- 3007663061
- 3030154823
- 3006629593
- 3029507159
- 3038195230
- 3033858988
- 9616868
- 3010701675
- 3010419931
- 3017376191
- 3030671618
- 2381321
- 3017499498
- 3005781611
- 3012840029
- 3029987245
- 3017618922
- 3014579161
- 3016731115
- 3005816808
- 3010486573
- 3016445768
- 3016815802
- 3014246581
- 3017494274
- 3014159202
- 3039304811
- 3017403359
- 3017618900
- 3005980667
- 3018783126
- 3014701704
- 1413787
- 3010162782
- 3007479587
- 9617642
- 3010683450
- 3008960188
- 3006639573
- 3011074933
- 3007336881
- 3004154770
- 3014264827
- 3000099306
- 2511556
- 3013735167
- 3020965557
- 3024088964
- 3013185096
- 3017610929
- 3008344782
- 8043847
- 3024999438
- 3012118920
- 3011180741
- 3015825358
- 3025428426
- 3041928150
- 3003799843
- 3042277637
- 3035880570
- 3007502533
- 3026753375
- 3030089889
- 3015282468
- 3008138005
- 3027341447
- 3015136935
- 3006750878
- 3004201548
- 2280705
- 2218158
- 1910469
- 3021245739
- 3016818428
- 3005607635
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