FDA product code JES: Floss, Dental
JES is the FDA product code for floss, dental. It is a Class I device, regulated under 21 CFR 872.6390 and reviewed by the Dental panel. FDA has cleared 62 510(k) submissions under JES, from 45 different applicants. The average 510(k) review took 73 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Floss, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.6390 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JES clearance
Top JES applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sewon Industry | 7 | 1987-03-19 |
| Oral-B Laboratories | 4 | 1995-04-27 |
| Ranir/Dcp Corp. | 3 | 1995-04-27 |
| Westone Products , Ltd. | 3 | 1991-09-30 |
| Whitehill Oral Technologies, Inc. | 2 | 1996-12-12 |
40 more applicants have JES clearances. See the full list in Caduvo.
Most recent JES clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091964 | Procter & Gamble Co. | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | 2009-09-24 | 85 |
| K964976 | Flossbrush Interdental Cleaner and Applicator | FLOSSBRUSH WITH FLUORIDE | 1997-05-06 | 145 |
| K963746 | Whitehill Oral Technologies, Inc. | IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID | 1996-12-12 | 86 |
| K944034 | Whitehill Oral Technologies, Inc. | PERIO-MED DENTAL FLOSS | 1995-07-25 | 357 |
| K952091 | John O. Butler Co. | VUTLER G.U.M. WITH FLUORIDE | 1995-06-28 | 56 |
Recalls for JES devices
openFDA lists no recalls for product code JES.
Frequently asked questions
What is FDA product code JES?
JES is the FDA product code for floss, dental. It is a Class I device, regulated under 21 CFR 872.6390 and reviewed by the Dental panel.
What device class is JES?
Class I, regulation 21 CFR 872.6390. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JES?
Across 62 cleared submissions the average was 73 days from receipt to decision (median 46).
Which companies have the most JES clearances?
Sewon Industry (7); Oral-B Laboratories (4); Ranir/Dcp Corp. (3); Westone Products , Ltd. (3); Whitehill Oral Technologies, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code JES
- Run a recall and safety report across every JES manufacturer
- Watch product code JES for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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