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510(k) K101771

Device
RELINE-IT MODEL RELINE-IT
Applicant
MAJESTIC DRUG CO., INC.
510(k) number
K101771
Product code
EBP  
Decision
Substantially Equivalent (SESE)
Decision date
2010-09-20
Date received
2010-06-24
Regulation
872.3560
Classification name
Reliner, Denture, Over The Counter
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROGER S MASTRONY
Address
848-1/2 Derby Ave. Orange CT US 06477 06477

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121318PROSOFTPerma Laboratories2012-06-06
K790589DENTURE-TIGHTDen-Mat Corp.1979-08-10

Legacy Summary#

summary

FDA Review#

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