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510(k) K790589

Device
DENTURE-TIGHT
Applicant
DEN-MAT CORP.
510(k) number
K790589
Product code
EBP  
Decision
Substantially Equivalent (SESE)
Decision date
1979-08-10
Date received
1979-03-27
Regulation
872.3560
Classification name
Reliner, Denture, Over The Counter
Medical specialty
Dental
Review panel
Dental
Device class
2
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 EBP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121318PROSOFTPerma Laboratories2012-06-06
K101771RELINE-IT MODEL RELINE-ITMajestic Drug Co., Inc.2010-09-20

Legacy Summary#

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FDA Review#

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