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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 K022258
Device Name B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
Applicant
B.T.I. Biotechnology Institute, Sl.
Parque Tecnologico De Alava
Leonardo Da Vinci, 14b
01510 Minano (Alava),  ES
Applicant Contact ALFREDOCO GOMEZ
Correspondent
B.T.I. Biotechnology Institute, Sl.
Parque Tecnologico De Alava
Leonardo Da Vinci, 14b
01510 Minano (Alava),  ES
Correspondent Contact ALFREDOCO GOMEZ
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/12/2002
Decision Date 09/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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