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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K061383
Device Name BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
Applicant
B.T.I. Biotechnology Institute, Sl.
Parque Tecnologico De Alava
Leonardo Da Vinci 14b
Minano(Alava),  ES 01510
Applicant Contact LEYRE Z HERNANDO
Correspondent
B.T.I. Biotechnology Institute, Sl.
Parque Tecnologico De Alava
Leonardo Da Vinci 14b
Minano(Alava),  ES 01510
Correspondent Contact LEYRE Z HERNANDO
Regulation Number872.3240
Classification Product Code
EJL  
Subsequent Product Code
NHA  
Date Received05/18/2006
Decision Date 08/03/2006
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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