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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
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