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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K053355
Device Name BTI INTERNA DENTAL IMPLANT SYSTEM
Applicant
B.T.I. Biotechnology Institute, Sl.
Parque Tecnologico De Alava
Leonardo Da Vinci 14b
Minano(Alava),  ES 01510
Applicant Contact ALFREDO GOMEZ MENGOD
Correspondent
B.T.I. Biotechnology Institute, Sl.
Parque Tecnologico De Alava
Leonardo Da Vinci 14b
Minano(Alava),  ES 01510
Correspondent Contact ALFREDO GOMEZ MENGOD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/02/2005
Decision Date 03/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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