ELRClass I

Post, Root Canal

21 CFR 872.3810 / Dental

ELR is the FDA product code for Post, Root Canal, a class I device type, regulated under 21 CFR 872.3810. As of 2026-09-10, FDA records hold 35 510(k) clearances under this code, the most recent dated 2006-03-30, and 2 recalls.

Classification record

Product code: ELR
Device name: Post, Root Canal
Regulation: 21 CFR 872.3810
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: 35
Ingested recalls: 2

Clearances, product code ELR

By decision year

35 clearances under product code ELR with a decision year between 1980 and 2006, 1994 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code ELR by decision year
Year	Clearances
1980	1
1981	1
1985	1
1987	1
1988	2
1990	2
1991	2
1993	1
1994	6
1995	2
1997	1
1998	3
2000	4
2001	1
2002	4
2003	1
2004	1
2006	1

Applicants with the most clearances

Product code ELR

Applicants holding the most 510(k) clearances under product code ELR
Applicant	Clearances
Coltene /Whaledent AG	3
Harald Nordin S.A.	3
J. Morita USA, Inc.	3
Ivoclar North America, Inc.	2
Ivoclar Vivadent, Inc.	2
Advanced Aeromedical, Inc.	1
Arcee Dental Products Co.	1
Bisco, Inc.	1
Bull Frog Mfg. Co.	1
Centrix, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 94 companies shown, in name order