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510(k) K121318

Device
PROSOFT
Applicant
PERMA LABORATORIES
510(k) number
K121318
Product code
EBP  
Decision
Substantially Equivalent (SESE)
Decision date
2012-06-06
Date received
2012-05-02
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
Yes

Applicant Contact#

Address
120 Wakefield Run Blvd. Hinckley OH US 44233 44233

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
K101771RELINE-IT MODEL RELINE-ITMajestic Drug Co., Inc.2010-09-20
K790589DENTURE-TIGHTDen-Mat Corp.1979-08-10

Legacy Summary#

summary

FDA Review#

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