Product code JES
- Device name
- Floss, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6390
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | Procter & Gamble Co. | 2009-09-24 |
| K964976 | FLOSSBRUSH WITH FLUORIDE | Flossbrush Interdental Cleaner and Applicator | 1997-05-06 |
| K963746 | IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID | Whitehill Oral Technologies, Inc. | 1996-12-12 |
| K944034 | PERIO-MED DENTAL FLOSS | Whitehill Oral Technologies, Inc. | 1995-07-25 |
| K952091 | VUTLER G.U.M. WITH FLUORIDE | John O. Butler Co. | 1995-06-28 |
| K951917 | JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS | Johnson & Johnson Consumer Products, Inc. | 1995-05-10 |
| K944886 | COLGATE PRECISION MINT WZXED DENTAL FLOSS | Colgate-Palmolive Co. | 1995-04-27 |
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | Oral-B Laboratories | 1995-04-27 |
| K942690 | RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 |
| K942689 | RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | Johnson & Johnson Consumer Products, Inc. | 1994-02-03 |
| K935522 | RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE | Ranir/Dcp Corp. | 1994-01-26 |
| K931353 | FLOSS PLUS | Floss Plus, Inc. | 1993-07-27 |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 |
| K921601 | ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE | Ultradent Products, Inc. | 1992-06-16 |
| K914962 | FUN FLOSS | Fun Floss Co. | 1991-12-30 |
| K913087 | DENTAL FLOSS | Westone Products , Ltd. | 1991-09-30 |
| K912430 | DENTAL FLOSS | Westone Products , Ltd. | 1991-09-30 |
| K911701 | G-FLOSS & G-FLOSS II | Implant Innovations International, Inc. | 1991-05-15 |
| K911470 | BUFFING FLOSS | Lamar Industries | 1991-05-15 |
| K905382 | SCRIBBON | Varnum Corp. | 1990-12-17 |
| K902325 | DENTAL CLEANING RINGS | H. Bernath & Assoc. | 1990-11-13 |
| K903712 | FLOSSIE TOOTHFLOSS | Flossie, Inc. | 1990-09-05 |
| K885056 | TWIXEL(TM) | Fouts Development, Inc. | 1989-01-04 |
| K884145 | FLOSER PLUS | Pacific Lin Intl., Co. | 1988-10-19 |
| K882571 | KOLYNOS DENTAL FLOSS | Whitehall Laboratories, Inc. | 1988-10-12 |
| K883024 | ORAL-B FLOSSERS | Oral-B Laboratories | 1988-08-26 |
| K883335 | COLGATE DENTAL FLOSS | Colgate-Palmolive Co. | 1988-08-26 |
| K882828 | DENTAL FLOSS PICK | Bik Pik | 1988-08-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10070942003695 | GUM® CRAYOLA TWISTABLES FLOSSERS | SUNSTAR AMERICAS, INC. | 2025-11-04 |
| 10304040189860 | Henry Schein | HENRY SCHEIN, INC. | 2025-01-30 |
| 10304040189853 | Henry Schein | HENRY SCHEIN, INC. | 2025-01-30 |
| 10304040169220 | Henry Schein | HENRY SCHEIN, INC. | 2023-06-25 |
| 10070942005026 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942751459 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942751497 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942751534 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942751572 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942751596 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942751619 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942751626 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 09358910000100 | Aura Bright | BRANDFARM PTY. LTD. | 2022-08-15 |
| 09358910000087 | Aura Bright | BRANDFARM PTY. LTD. | 2022-08-15 |
| 10304040029326 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| 10304040029173 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| 10304040029296 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| 10304040029319 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| 10304040036614 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036621 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036638 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036645 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036652 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036669 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036676 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036683 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036690 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036706 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036607 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |
| 10304040036591 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |