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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 K061807
Device Name SPI ART ABUTMENTS
Applicant
Thommen Medical AG
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact Floyd Larson
Correspondent
Thommen Medical AG
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact Floyd Larson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/27/2006
Decision Date 07/31/2006
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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