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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 K101005
Device Name ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
Applicant
Astra Tech AB
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact LINDA SCHULZ
Correspondent
Astra Tech AB
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact LINDA SCHULZ
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/12/2010
Decision Date 06/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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