EJKClass II

Liner, Cavity, Calcium Hydroxide

21 CFR 872.3250 / Dental

EJK is the FDA product code for Liner, Cavity, Calcium Hydroxide, a class II device type, regulated under 21 CFR 872.3250. As of 2026-09-10, FDA records hold 78 510(k) clearances under this code, the most recent dated 2026-07-21, and one recall.

Classification record

Product code: EJK
Device name: Liner, Cavity, Calcium Hydroxide
Regulation: 21 CFR 872.3250
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 78
Ingested recalls: 1

Clearances, product code EJK

By decision year

78 clearances under product code EJK with a decision year between 1976 and 2026, 1994 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code EJK by decision year
Year	Clearances
1976	1
1978	3
1979	1
1980	2
1981	1
1982	1
1983	2
1984	2
1985	1
1986	1
1987	2
1988	2
1989	3
1990	5
1991	5
1992	5
1993	2
1994	6
1995	2
1996	1
1997	4
1998	1
2000	1
2001	2
2002	2
2004	1
2006	2
2011	1
2012	3
2013	1
2014	1
2015	3
2018	1
2019	1
2020	1
2021	1
2022	1
2023	1
2026	2

Applicants with the most clearances

Product code EJK

Applicants holding the most 510(k) clearances under product code EJK
Applicant	Clearances
Sybron Dental Specialties, Inc.	5
Ultradent Products Inc.	5
Bisco Inc	4
Centrix, Inc.	4
Dentsply Intl.	4
Pulpdent Corporation	4
Espe GmbH (US)	3
Voco GmbH	3
Ivoclar North America, Inc.	2
Kerr Corporation (Danbury)	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order