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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K120414
Device Name OSSEOSPEED PLUS
Applicant
Astra Tech AB
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact LINDA K SCHULZ
Correspondent
Astra Tech AB
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/10/2012
Decision Date 07/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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