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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 K032351
Device Name THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
Applicant
BioHorizons Implant Systems, Inc.
One Perimeter Park S.
Suite 230, S.
Birmingham,  AL  35243
Applicant Contact WINSTON D GREER
Correspondent
BioHorizons Implant Systems, Inc.
One Perimeter Park S.
Suite 230, S.
Birmingham,  AL  35243
Correspondent Contact WINSTON D GREER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/30/2003
Decision Date 10/21/2003
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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