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510(k) K772315

Device
KWIKAP
Applicant
DEN-MAT CORP.
510(k) number
K772315
Product code
EMB  
Decision
Substantially Equivalent (SESE)
Decision date
1978-01-03
Date received
1977-12-19
Regulation
872.3275
Classification name
Zinc Oxide Eugenol
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EMB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K161630Provicol QM PlusVoco GmbH2016-09-15
K120695DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KITDentist IN A Box Pty., Ltd.2012-06-12
K110759TEMPOCEMDmg USA, Inc.2011-06-10
K073539PROVISA CEMCavex Holland BV2008-01-31
K020158NON-EUGENOL TEMPORARY CEMENTJ. Morita USA, Inc.2002-03-07
K941066DENTAL 911L.A.F. Industries, Inc.1995-05-24
K861681DENTIMEDIC DENTAL EMERGENCY KITDentimedic1986-09-23
K862745EUGENOL USPE&D Dental Manufacturing Co.1986-07-31
K821581DEN TEMPMajestic Drug Co., Inc.1982-06-14
K801779OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENTOxy Dental Products, Inc.1980-08-07

Legacy Summary#

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FDA Review#

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