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510(k) K903672

Device
DENE BRIDGE
Applicant
DIROTIAN PTY. LTD.
510(k) number
K903672
Product code
EKO  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-05
Date received
1990-08-14
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#

Contact
RICHARD BURGESS
Address
6a Addison Rd. Pennington 5013 South Australia AU

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
K892255DENTAL ROOT ELEVATORZinnanti Surgical Instruments, Inc.1989-05-01
K780722ADVANCED DENTURE SYSTEMAdvanced Marketing Research Co.1978-05-26
K760768FLEXIDENT DENTUREFlexodent Corp.1976-10-15

Legacy Summary#

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FDA Review#

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