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

Broach, Endodontic

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

EKW is the FDA product code for Broach, Endodontic, 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
EKW
Device name
Broach, Endodontic
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 EKW

By decision year
7 clearances under product code EKW with a decision year between 1976 and 1987, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EKW by decision year
YearClearances
19761
19801
19821
19831
19861
19872

Applicants with the most clearances

Product code EKW
Applicants holding the most 510(k) clearances under product code EKW
ApplicantClearances
Adp Intl., Inc.1
Advanced Medical, Inc.1
Ipco Corp.1
Treace Medical, Inc.1
Union Branch1
Union Broach, Div. Moyco Industries, Inc.1
Biomet Microfixation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order