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510(k) K760768

Device
FLEXIDENT DENTURE
Applicant
FLEXODENT CORP.
510(k) number
K760768
Product code
EKO  
Decision
Substantially Equivalent (SESE)
Decision date
1976-10-15
Date received
1976-10-04
Regulation
872.3600
Classification name
Denture Preformed (partially Prefabricated Denture)
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 EKO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K903672DENE BRIDGEDirotian Pty. , Ltd.1990-12-05
K892255DENTAL ROOT ELEVATORZinnanti Surgical Instruments, Inc.1989-05-01
K780722ADVANCED DENTURE SYSTEMAdvanced Marketing Research Co.1978-05-26

Legacy Summary#

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FDA Review#

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