EKRClass I

Plugger, Root Canal, Endodontic

21 CFR 872.4565 / Dental

EKR is the FDA product code for Plugger, Root Canal, Endodontic, a class I device type, regulated under 21 CFR 872.4565. As of 2026-09-10, FDA records hold 6 510(k) clearances under this code, the most recent dated 2006-06-05, and 3 recalls.

Classification record

Product code: EKR
Device name: Plugger, Root 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: 3

Clearances, product code EKR

By decision year

6 clearances under product code EKR with a decision year between 1979 and 2006, 2004 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code EKR by decision year
Year	Clearances
1979	1
1983	1
1986	1
2004	2
2006	1

Applicants with the most clearances

Product code EKR

Applicants holding the most 510(k) clearances under product code EKR
Applicant	Clearances
B&L Biotech Co., Inc	1
Dentsply Intl.	1
Sybron Endo/Analytic	1
Techdent, Inc.	1
Union Branch	1
Young O/S, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 140 companies shown, in name order