JES · Floss, Dental
Dental · 21 CFR 872.6390 · Class 1
Overview
| Product Code | JES |
|---|---|
| Device Name | Floss, Dental |
| Regulation | 21 CFR 872.6390 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use.
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 § 872.9.
Recent Cleared Devices (20 of 62)
Showing 20 most recent of 62 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | Procter & Gamble Co. | Sep 24, 2009 | SESE |
| K964976 | FLOSSBRUSH WITH FLUORIDE | Flossbrush Interdental Cleaner and Applicator | May 6, 1997 | SESE |
| K963746 | IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID | Whitehill Oral Technologies, Inc. | Dec 12, 1996 | SESE |
| K944034 | PERIO-MED DENTAL FLOSS | Whitehill Oral Technologies, Inc. | Jul 25, 1995 | SESE |
| K952091 | VUTLER G.U.M. WITH FLUORIDE | John O. Butler Co. | Jun 28, 1995 | SESE |
| K951917 | JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS | Johnson & Johnson Consumer Products, Inc. | May 10, 1995 | SESE |
| K944886 | COLGATE PRECISION MINT WZXED DENTAL FLOSS | Colgate-Palmolive Co. | Apr 27, 1995 | SESE |
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | Oral-B Laboratories | Apr 27, 1995 | SESE |
| K942690 | RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | Apr 27, 1995 | SESE |
| K942689 | RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | Apr 27, 1995 | SESE |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | Johnson & Johnson Consumer Products, Inc. | Feb 3, 1994 | SESE |
| K935522 | RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE | Ranir/Dcp Corp. | Jan 26, 1994 | SESE |
| K931353 | FLOSS PLUS | Floss Plus, Inc. | Jul 27, 1993 | SESE |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Oral-B Laboratories | Jan 28, 1993 | SESE |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Oral-B Laboratories | Jan 28, 1993 | SESE |
| K921601 | ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE | Ultradent Products, Inc. | Jun 16, 1992 | SESE |
| K914962 | FUN FLOSS | Fun Floss Co. | Dec 30, 1991 | SESE |
| K913087 | DENTAL FLOSS | Westone Products , Ltd. | Sep 30, 1991 | SESE |
| K912430 | DENTAL FLOSS | Westone Products , Ltd. | Sep 30, 1991 | SESE |
| K911701 | G-FLOSS & G-FLOSS II | Implant Innovations International, Inc. | May 15, 1991 | SESE |
Top Applicants
- Sewon Industry — 7 clearances
- Oral-B Laboratories — 4 clearances
- Westone Products , Ltd. — 3 clearances
- Ranir/Dcp Corp. — 3 clearances
- Whitehill Oral Technologies, Inc. — 2 clearances
