EMB · Class I · 21 CFR 872.3275

FDA Product Code EMB: Zinc Oxide Eugenol

Leading manufacturers include J. Morita USA, Inc., Cavex Holland BV and Dmg USA, Inc..

11

Total

11

Cleared

92d

Avg days

1978

Since

FDA 510(k) Cleared Zinc Oxide Eugenol Devices (Product Code EMB)

11 devices

1–11 of 11

Cleared Sep 15, 2016

Provicol QM Plus

Cleared Jun 12, 2012

DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT

Dentist IN A Box Pty., Ltd.

Cleared Jun 10, 2011

Cleared Jan 31, 2008

Cavex Holland BV

Cleared Mar 07, 2002

NON-EUGENOL TEMPORARY CEMENT

J. Morita USA, Inc.

Cleared May 24, 1995

L.A.F. Industries, Inc.

Cleared Sep 23, 1986

DENTIMEDIC DENTAL EMERGENCY KIT

Cleared Jul 31, 1986

E&D Dental Manufacturing Co.

Cleared Jun 14, 1982

Majestic Drug Co., Inc.

Cleared Aug 07, 1980

OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT

Oxy Dental Products, Inc.

Cleared Jan 03, 1978

About Product Code EMB - Regulatory Context

Related FDA 510(k) Regulatory Insights