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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K040769
Device Name STRUCTUR 2 SC
Applicant
Voco GmbH
19379 Blue Lake Loop
Bend,  OR  97702
Applicant Contact GERALD W SHIPPS
Correspondent
Voco GmbH
19379 Blue Lake Loop
Bend,  OR  97702
Correspondent Contact GERALD W SHIPPS
Regulation Number872.3770
Classification Product Code
EBG  
Date Received03/25/2004
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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