Pick, Massaging
A Massaging Pick is a dental hygiene instrument used to stimulate and massage gum tissue and to remove food debris from interproximal spaces, supporting periodontal circulation and oral health. It is classified as FDA Class 1 (lowest risk), subject to general controls. The product code is JET, regulated under 21 CFR 872.6650, within the Dental medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations, indicating a reduced regulatory burden for manufacturers.
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Basic Information
- Product Code
- JET
- Device Class
- FDA class 1
- Regulation Number
- 872.6650
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963747 | REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. | Dec 16, 1996 | Substantially Equivalent | Whitehill Manufacturing, Inc. |
| K942633 | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | Apr 27, 1995 | Substantially Equivalent | Oral-B Laboratories |
| K930178 | ELECTRO FLOSS | Jul 28, 1993 | Substantially Equivalent | Arizona Implant Dentistry |
| K911418 | GUM MASSAGER | Jul 17, 1991 | Substantially Equivalent | Burn-Henderson Partnership |
| K885189 | MASSAGING PICK FOR ORAL HYGIENE | Mar 17, 1989 | Substantially Equivalent | Dentek Corp. |
| K890910 | PLAKOF | Mar 16, 1989 | Substantially Equivalent | Ximex, Ltd. |
| K883225 | FLOSSIE | Aug 30, 1988 | Substantially Equivalent | Richard G. Deniro |
| K881900 | PERMA-PIC PLASTIC TOOTHPICK | Jun 01, 1988 | Substantially Equivalent | The Perma-Pic Co. |
| K881046 | SUPER PIK MASSAGING PICK FOR ORAL HYGIENE | May 13, 1988 | Substantially Equivalent | U.S. Dentek Corp. |
| K860779 | ULTRAPROX, INTERPROXIMAL TOOTHBRUSH | Apr 02, 1986 | Substantially Equivalent | William J. Forni, D.D.S. |
| K850775 | DENTAL MASSAGING PICKS | Apr 10, 1985 | Substantially Equivalent | L.A.K. Ent., Inc. |
| K844238 | ORAPIK PERIODONTAL SCALER | Dec 03, 1984 | Substantially Equivalent | Dental Concepts, LLC |
| K832949 | SANODENT DOUBLE-ENDED INTERDENTAL CLEAN | Oct 04, 1983 | Substantially Equivalent | Coopercare, Inc. |
| K821629 | FIXIDENT | Jun 14, 1982 | Substantially Equivalent | Moyco Industries, Inc. |
| K820979 | RESILIENT GUM EXERCISER | May 10, 1982 | Substantially Equivalent | Martin A. Hass, D.D.S. |
FEI Numbers
This FDA classification entry is associated with 124 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 125 registration numbers. Click on an entry to view related FDA registrations.