GC AADVA ABUTMENT

Abutment, Implant, Dental, Endosseous

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Aadva Abutment.

Pre-market Notification Details

Device IDK072100
510k NumberK072100
Device Name:GC AADVA ABUTMENT
ClassificationAbutment, Implant, Dental, Endosseous
Applicant GC AMERICA, INC. 1025 EVERETT ROAD, SUITE 100 Lake Forest,  IL  60045
ContactH. Carl Jenkins
CorrespondentH. Carl Jenkins
GC AMERICA, INC. 1025 EVERETT ROAD, SUITE 100 Lake Forest,  IL  60045
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-31
Decision Date2008-02-14

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