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EMB — Zinc Oxide Eugenol Class I

FDA Device Classification

Classification Details

Product Code
EMB
Device Class
Class I
Regulation Number
872.3275
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K161630vocoProvicol QM PlusSeptember 15, 2016
K120695dentist in a box ptyDENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KITJune 12, 2012
K110759dmg usaTEMPOCEMJune 10, 2011
K073539cavex hollandPROVISA CEMJanuary 31, 2008
K020158j. morita usaNON-EUGENOL TEMPORARY CEMENTMarch 7, 2002
K941066l.a.f. industriesDENTAL 911May 24, 1995
K861681dentimedicDENTIMEDIC DENTAL EMERGENCY KITSeptember 23, 1986
K862745e and d dental manufacturingEUGENOL USPJuly 31, 1986
K821581majestic drug coDEN TEMPJune 14, 1982
K801779oxy dental productsOXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENTAugust 7, 1980
K772315den-matKWIKAPJanuary 3, 1978