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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 K111390
Device Name SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..
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 Received05/18/2011
Decision Date 09/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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