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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 K111984
Device Name SPI VARIO ANGLED ABUTMENT
Applicant
Thommen Medical AG
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact LINDA K SCHULZ
Correspondent
Thommen Medical AG
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/12/2011
Decision Date 11/10/2011
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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