JET · Pick, Massaging
Dental · 21 CFR 872.6650 · Class 1
Overview
| Product Code | JET |
|---|---|
| Device Name | Pick, Massaging |
| Regulation | 21 CFR 872.6650 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A massaging pick or tip for oral hygiene is a rigid, pointed device intended to be used manually to stimulate and massage the gums to promote good periodontal (gum) condition.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963747 | REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. | Whitehill Manufacturing, Inc. | Dec 16, 1996 | SESE |
| K942633 | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | Oral-B Laboratories | Apr 27, 1995 | SESE |
| K930178 | ELECTRO FLOSS | Arizona Implant Dentistry | Jul 28, 1993 | SESE |
| K911418 | GUM MASSAGER | Burn-Henderson Partnership | Jul 17, 1991 | SESE |
| K885189 | MASSAGING PICK FOR ORAL HYGIENE | Dentek Corp. | Mar 17, 1989 | SESE |
| K890910 | PLAKOF | Ximex, Ltd. | Mar 16, 1989 | SESE |
| K883225 | FLOSSIE | Richard G. Deniro | Aug 30, 1988 | SESE |
| K881900 | PERMA-PIC PLASTIC TOOTHPICK | The Perma-Pic Co. | Jun 1, 1988 | SESE |
| K881046 | SUPER PIK MASSAGING PICK FOR ORAL HYGIENE | U.S. Dentek Corp. | May 13, 1988 | SESE |
| K860779 | ULTRAPROX, INTERPROXIMAL TOOTHBRUSH | William J. Forni, D.D.S. | Apr 2, 1986 | SESE |
| K850775 | DENTAL MASSAGING PICKS | L.A.K. Ent., Inc. | Apr 10, 1985 | SESE |
| K844238 | ORAPIK PERIODONTAL SCALER | Dental Concepts, LLC | Dec 3, 1984 | SESE |
| K832949 | SANODENT DOUBLE-ENDED INTERDENTAL CLEAN | Coopercare, Inc. | Oct 4, 1983 | SESE |
| K821629 | FIXIDENT | Moyco Industries, Inc. | Jun 14, 1982 | SESE |
| K820979 | RESILIENT GUM EXERCISER | Martin A. Hass, D.D.S. | May 10, 1982 | SESE |
Top Applicants
- Arizona Implant Dentistry — 1 clearance
- Burn-Henderson Partnership — 1 clearance
- Coopercare, Inc. — 1 clearance
- Dental Concepts, LLC — 1 clearance
- Dentek Corp. — 1 clearance
