EJK · Class II · 21 CFR 872.3250

FDA Product Code EJK: Liner, Cavity, Calcium Hydroxide

Leading manufacturers include Ultradent Products, Inc., Centrix, Inc. and Sybron Dental Specialties, Inc..

78

Total

78

Cleared

91d

Avg days

1976

Since

78 devices

49–72 of 78

Cleared Jul 31, 1990

FUJI LINING CEMENT LIGHT CURE

G-C Intl. Corp.

Cleared Mar 27, 1990

INTERFACE - CAVITY LINER

Scientific Pharmaceuticals, Inc.

Cleared Jan 16, 1990

BASIC CALCIUM HYDROXIDE LINER

Ivoclar North America, Inc.

Cleared Nov 29, 1988

GLASS IONOMER BASE

Cleared Feb 26, 1988

Cleared Aug 26, 1987

Kerr Corporation (Danbury)

Cleared Jul 13, 1984

KERR SEALAPEX ROOT CANAL SEALER

Cleared Jun 30, 1983

NU-CAP CALCIUM HYDROX. PULP CAPPING

Coe Laboratories, Inc.

Cleared Mar 23, 1982

Cleared Nov 12, 1980

Vivadent (Usa), Inc.

Cleared Oct 22, 1979

MONOJECT PULP-CAPPING MATERIAL

Sherwood Medical Co.

Cleared Dec 20, 1978

LINER, CAVITY CALCIUM HYDROXIDE

Kerr Corporation (Danbury)

Cleared Mar 15, 1978