510(k) K844238
- Device
- ORAPIK PERIODONTAL SCALER
- Applicant
- DENTAL CONCEPTS LLC.
- 510(k) number
- K844238
- Product code
- JET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-12-03
- Date received
- 1984-11-01
- 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
- SETH NATTER
- Address
- 25 W. 43rd. St. New York NY US 10036 10036
FDA Registration Numbers#
- 3011089435
- 2183301
- 3005558160
- 3006113202
- 3014468707
- 3011964664
- 3009926836
- 3005581016
- 3008770703
- 3012360263
- 3004789183
- 3007327603
- 2087561
- 3010701675
- 2018957
- 3033918991
- 2133714
- 3013972866
- 3038718579
- 3009171220
- 3018762668
- 3005816808
- 3015139713
- 3010486573
- 3011554142
- 3008808087
- 2027062
- 3009431661
- 3009488700
- 3017417635
- 9615399
- 9710299
- 3016075921
- 3007421127
- 9614443
- 3006639700
- 3004305946
- 9616128
- 1413787
- 3007479587
- 1419489
- 3011497834
- 3016450032
- 3025414363
- 3002911411
- 3006639573
- 3009124884
- 3010864832
- 3042283835
- 3003761382
- 3012133441
- 3008346537
- 3006789197
- 3008344782
- 3006536571
- 1836161
- 3006400536
- 3008925277
- 3009560600
- 3008808082
- 3010119775
- 3024512680
- 3007663058
- 3014316197
- 3017268636
- 3012118920
- 9615031
- 3003487388
- 3004082121
- 1530449
- 1421879
- 3012341715
- 2920519
- 3003799843
- 3005277354
- 1825660
- 3018975080
- 3004069780
- 3013734586
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 |
| K911418 | GUM MASSAGER | Burn-Henderson Partnership | 1991-07-17 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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