THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT

Implant, Endosseous, Root-form

BIOHORIZONS IMPLANT SYSTEMS, INC.

The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for The Maestro System 3.0mm Diameter Implant.

Pre-market Notification Details

Device IDK032351
510k NumberK032351
Device Name:THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
ClassificationImplant, Endosseous, Root-form
Applicant BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham,  AL  35243
ContactWinston D Greer
CorrespondentWinston D Greer
BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham,  AL  35243
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-30
Decision Date2003-10-21
Summary:summary

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