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

File, Pulp Canal, Endodontic

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

EKS is the FDA product code for File, Pulp Canal, Endodontic, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
EKS
Device name
File, Pulp Canal, 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
31
Ingested recalls
3

Clearances, product code EKS

By decision year
31 clearances under product code EKS with a decision year between 1980 and 2006, 1982 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code EKS by decision year
YearClearances
19801
19812
19826
19861
19874
19893
19902
19913
19932
19941
19951
19961
19972
20011
20061

Applicants with the most clearances

Product code EKS
Applicants holding the most 510(k) clearances under product code EKS
ApplicantClearances
Union Broach, Div. Moyco Industries, Inc.4
Miltex, Inc.2
Tycom Dental2
United Dental Mfg., Inc.2
A Company, Inc.1
Angiosystems, Inc.1
C & S Microinstruments, Ltd.1
Coltene, Inc.1
Dental Power, Inc.1
Dentauraum, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 157 companies shown, in name order