510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JESClass I

Floss, Dental

21 CFR 872.6390 / Dental
FDA source (opens on fda.gov)

JES is the FDA product code for Floss, Dental, a class I device type, regulated under 21 CFR 872.6390. As of , FDA records hold 62 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JES
Device name
Floss, Dental
Regulation
21 CFR 872.6390
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
62
Ingested recalls
0

Clearances, product code JES

By decision year
62 clearances under product code JES with a decision year between 1976 and 2009, 1988 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code JES by decision year
YearClearances
19761
19792
19815
19823
19832
19843
19853
19866
19875
19887
19891
19903
19915
19921
19933
19942
19957
19961
19971
20091

Applicants with the most clearances

Product code JES
Applicants holding the most 510(k) clearances under product code JES
ApplicantClearances
Sewon Industry7
Oral-B Laboratories4
Ranir/Dcp Corp.3
Westone Products, Ltd.3
Colgate-Palmolive Company2
Flossrite Corp.2
Johnson & Johnson Consumer Products, Inc.2
Whitehill Oral Technologies, Inc.2
Agri Hort1
Almore Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 337 companies shown, in name order