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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 K091387
Device Name BTI DENTAL IMPLANT 5.5-6.5
Applicant
B.T.I. Biotechnology Institute, Sl.
Leonardo Da Vinci, 14 B
Minano Menor, Alava,  ES 01510
Applicant Contact ALFREDO GOMEZ
Correspondent
B.T.I. Biotechnology Institute, Sl.
Leonardo Da Vinci, 14 B
Minano Menor, Alava,  ES 01510
Correspondent Contact ALFREDO GOMEZ
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/11/2009
Decision Date 01/22/2010
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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