510(k) K911418
- Device
- Gum Massager
- Applicant
- BURN-HENDERSON PARTNERSHIP
- 510(k) number
- K911418
- Product code
- JET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-17
- Date received
- 1991-04-01
- Regulation
- 872.6650
- Classification name
- Pick, Massaging
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHESTER A BURN
- Address
- 10 S. Potomac Suite B Aurora CO US 80012 80012
FDA Registration Numbers#
- 3019912897
- 3008076203
- 3038718579
- 2920519
- 3014316197
- 9710299
- 3010872518
- 3004605493
- 3015989868
- 3021245739
- 3033918991
- 3003761382
- 3011482376
- 2087561
- 1421879
- 3005558160
- 3011545201
- 3006789197
- 3017268636
- 3033615362
- 3007327603
- 3025414363
- 9615399
- 3011964664
- 1530449
- 1051594
- 3011862887
- 3006400536
- 3003965504
- 3006536571
- 3013734586
- 3009488700
- 3005277354
- 3019741877
- 3008346537
- 3008478778
- 3003799843
- 3004096300
- 3010701675
- 1836161
- 3008344782
- 9614443
- 1419489
- 3005581016
- 3009431661
- 9615008
- 3003994666
- 3012341715
- 3011089435
- 3009560600
- 3004082121
- 3012360263
- 3003618527
- 2086043
- 2027062
- 3010028831
- 3010486573
- 3016075921
- 3007345409
- 3008808087
- 3006113202
- 3018975080
- 1718912
- 3009124884
- 3001655856
- 1719513
- 1051614
- 3007663058
- 2183301
- 1825660
- 2133714
- 1941138
- 3007421127
- 3003491259
- 2029275
- 3002911411
- 3016450032
- 3009926836
- 3011497834
- 3003487388
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JET#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963747 | REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. | Whitehill Manufacturing, Inc. | 1996-12-16 |
| K942633 | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | Oral-B Laboratories | 1995-04-27 |
| K930178 | ELECTRO FLOSS | Arizona Implant Dentistry | 1993-07-28 |
| K885189 | MASSAGING PICK FOR ORAL HYGIENE | Dentek Corp. | 1989-03-17 |
| K890910 | PLAKOF | Ximex, Ltd. | 1989-03-16 |
| K883225 | FLOSSIE | Richard G. Deniro | 1988-08-30 |
| K881900 | PERMA-PIC PLASTIC TOOTHPICK | The Perma-Pic Co. | 1988-06-01 |
| K881046 | SUPER PIK MASSAGING PICK FOR ORAL HYGIENE | U.S. Dentek Corp. | 1988-05-13 |
| K860779 | ULTRAPROX, INTERPROXIMAL TOOTHBRUSH | William J. Forni, D.D.S. | 1986-04-02 |
| K850775 | DENTAL MASSAGING PICKS | L.A.K. Ent., Inc. | 1985-04-10 |
| K844238 | ORAPIK PERIODONTAL SCALER | Dental Concepts, LLC | 1984-12-03 |
| K832949 | SANODENT DOUBLE-ENDED INTERDENTAL CLEAN | Coopercare, Inc. | 1983-10-04 |
| K821629 | FIXIDENT | Moyco Industries, Inc. | 1982-06-14 |
| K820979 | RESILIENT GUM EXERCISER | Martin A. Hass, D.D.S. | 1982-05-10 |