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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K063106
Device Name REVOIS IMPLANT SYSTEM
Applicant
CURASAN AG
109 SHORE DRIVE
GARNER,  NC  27529
Applicant Contact ERIC WEICHERT
Correspondent
CURASAN AG
109 SHORE DRIVE
GARNER,  NC  27529
Correspondent Contact ERIC WEICHERT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/11/2006
Decision Date 06/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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