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

Plier, Orthodontic

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

JEX is the FDA product code for Plier, Orthodontic, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JEX
Device name
Plier, Orthodontic
Regulation
21 CFR 872.4565
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
7
Ingested recalls
0

Clearances, product code JEX

By decision year
7 clearances under product code JEX with a decision year between 1976 and 1995, 1992 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JEX by decision year
YearClearances
19761
19841
19851
19922
19941
19951

Applicants with the most clearances

Product code JEX
Applicants holding the most 510(k) clearances under product code JEX
ApplicantClearances
Unitek Corp.3
Adp Intl., Inc.1
Dentauraum, Inc.1
Sybron Dental Specialties, Inc.1
Unitex Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 229 companies shown, in name order