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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 K083876
Device Name SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT
Applicant
Cendres & Metaux SA
Rue De Boujean 122
Biel/Bienne,  CH 2501
Applicant Contact PETER W FLEETWOOD
Correspondent
Cendres & Metaux SA
Rue De Boujean 122
Biel/Bienne,  CH 2501
Correspondent Contact PETER W FLEETWOOD
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/29/2008
Decision Date 02/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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