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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture Preformed (Partially Prefabricated Denture)
510(k) Number K903672
Device Name DENE BRIDGE
Applicant
Dirotian Pty. , Ltd.
6a Addison Rd.
Pennington 5013
South Australia,  AU
Applicant Contact RICHARD BURGESS
Correspondent
Dirotian Pty. , Ltd.
6a Addison Rd.
Pennington 5013
South Australia,  AU
Correspondent Contact RICHARD BURGESS
Regulation Number872.3600
Classification Product Code
EKO  
Date Received08/14/1990
Decision Date 12/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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