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

Reamer, Pulp Canal, Endodontic

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

EKP is the FDA product code for Reamer, Pulp Canal, Endodontic, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EKP
Device name
Reamer, 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
6
Ingested recalls
0

Clearances, product code EKP

By decision year
6 clearances under product code EKP with a decision year between 1977 and 1982, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EKP by decision year
YearClearances
19773
19801
19822

Applicants with the most clearances

Product code EKP
Applicants holding the most 510(k) clearances under product code EKP
ApplicantClearances
Cemco Tool Co., Inc.1
Ipco Corp.1
Janneck Ent. of Texas1
Ransom & Randolph. LLC.1
Union Broach, Div. Moyco Industries, Inc.1
United Dental Mfg., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 58 companies shown, in name order