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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 K070533
Device Name BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS
Applicant
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
LEONARDO DA VINCI, 14 B
MINANO MENOR, ALAVA,  ES 01510
Applicant Contact ;EYRE Z HERNANDO
Correspondent
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
LEONARDO DA VINCI, 14 B
MINANO MENOR, ALAVA,  ES 01510
Correspondent Contact ;EYRE Z HERNANDO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/26/2007
Decision Date 06/21/2007
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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