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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 K102382
Device Name SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT
Applicant
Cendres & Metaux SA
Rue De Boujean 122
Biel/Bienne,  CH 2501
Applicant Contact TANJA BONGNI
Correspondent
Cendres & Metaux SA
Rue De Boujean 122
Biel/Bienne,  CH 2501
Correspondent Contact TANJA BONGNI
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/23/2010
Decision Date 12/03/2010
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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