BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS

Abutment, Implant, Dental, Endosseous

BIOHORIZONS IMPLANT SYSTEMS, INC.

The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Plastic Temporary Abutments.

Pre-market Notification Details

Device IDK053099
510k NumberK053099
Device Name:BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham,  AL  35243
ContactWinston Greer
CorrespondentWinston Greer
BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham,  AL  35243
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-03
Decision Date2006-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847236014681 K053099 000

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