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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 K972313
Device Name THE MAESTRO SYSTEM
Applicant
BioHorizons Implant Systems, Inc.
2129 Montgomery Way
Birmingham,  AL  35209
Applicant Contact R. STEVEN BOGGAN
Correspondent
BioHorizons Implant Systems, Inc.
2129 Montgomery Way
Birmingham,  AL  35209
Correspondent Contact R. STEVEN BOGGAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/20/1997
Decision Date 09/16/1997
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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