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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 K130618
Device Name SFI-ANCHOR
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 Received03/07/2013
Decision Date 03/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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