EJRClass I

Agent, Polishing, Abrasive, Oral Cavity

21 CFR 872.6030 / Dental

EJR is the FDA product code for Agent, Polishing, Abrasive, Oral Cavity, a class I device type, regulated under 21 CFR 872.6030. As of 2026-09-10, FDA records hold 77 510(k) clearances under this code, the most recent dated 2017-09-11, and one recall.

Classification record

Product code: EJR
Device name: Agent, Polishing, Abrasive, Oral Cavity
Regulation: 21 CFR 872.6030
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: 77
Ingested recalls: 1

Clearances, product code EJR

By decision year

77 clearances under product code EJR with a decision year between 1976 and 2017, 1990 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code EJR by decision year
Year	Clearances
1976	2
1977	2
1978	1
1979	1
1980	1
1981	3
1982	2
1984	3
1985	4
1986	7
1987	4
1988	1
1989	2
1990	8
1991	4
1992	3
1993	1
1994	4
1997	1
1999	3
2000	2
2003	1
2004	7
2006	2
2007	1
2010	2
2011	2
2012	1
2014	1
2017	1

Applicants with the most clearances

Product code EJR

Applicants holding the most 510(k) clearances under product code EJR
Applicant	Clearances
Scientific Pharmaceuticals, Inc.	7
Dentsply Intl.	5
Imd, Inc.	3
Pulpdent Corporation	3
Antraco, Inc.	2
Block Drug Company, Inc.	2
Challenge Products, Inc.	2
GC America Inc.	2
Germiphene Corp.	2
Johnson & Johnson Professionals, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 139 companies shown, in name order