EMB · Class I · 21 CFR 872.3275

FDA Product Code EMB: Zinc Oxide Eugenol

Leading manufacturers include Voco GmbH, Den-Mat Corp. and J. Morita 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
K161630
Voco GmbH
Dental · 94d
Cleared Jun 12, 2012
DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
K120695
Dentist IN A Box Pty., Ltd.
Dental · 97d
Cleared Jun 10, 2011
TEMPOCEM
K110759
Dmg USA, Inc.
Dental · 84d
Cleared Jan 31, 2008
PROVISA CEM
K073539
Cavex Holland BV
Dental · 45d
Cleared Mar 07, 2002
NON-EUGENOL TEMPORARY CEMENT
K020158
J. Morita USA, Inc.
Dental · 49d
Cleared Jan 03, 1978
KWIKAP
K772315
Den-Mat Corp.
Dental · 15d

About Product Code EMB - Regulatory Context