FDA 510(k) Applications for Medical Device Product Code "EMB"
(Zinc Oxide Eugenol)

FDA 510(k) Number Applicant Device Name Decision Date
K073539 CAVEX HOLLAND B.V. PROVISA CEM 01/31/2008
K120695 DENTIST IN A BOX PTY. LTD DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT 06/12/2012
K110759 DMG USA, INC. TEMPOCEM 06/10/2011
K020158 J. MORITA USA, INC. NON-EUGENOL TEMPORARY CEMENT 03/07/2002
K161630 VOCO GMBH Provicol QM Plus 09/15/2016


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