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

Unit, Electrosurgical, And Accessories, Dental

21 CFR 872.4920 / Dental
FDA source (opens on fda.gov)

EKZ is the FDA product code for Unit, Electrosurgical, And Accessories, Dental, a class II device type, regulated under 21 CFR 872.4920. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EKZ
Device name
Unit, Electrosurgical, And Accessories, Dental
Regulation
21 CFR 872.4920
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
19
Ingested recalls
1

Clearances, product code EKZ

By decision year
19 clearances under product code EKZ with a decision year between 1983 and 2022, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EKZ by decision year
YearClearances
19831
19852
19921
19941
19951
19962
19982
20002
20021
20031
20052
20072
20221

Applicants with the most clearances

Product code EKZ
Applicants holding the most 510(k) clearances under product code EKZ
ApplicantClearances
Macan Engineering Co.2
Analytic Technology1
ArthroCare Corporation1
Coltene /Whaledent AG1
Coulter Electronics, Inc.1
Diagnostic Data, Inc.1
Ellman Intl., Inc.1
Ipco Corp.1
J. Morita USA, Inc.1
Medisurg, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code