Duranext Abutments

Abutment, Implant, Dental, Endosseous

Elegant Dental Corp.

The following data is part of a premarket notification filed by Elegant Dental Corp. with the FDA for Duranext Abutments.

Pre-market Notification Details

Device IDK200355
510k NumberK200355
Device Name:Duranext Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Elegant Dental Corp. 2308 McDonald Avenue Brooklyn,  NY  11223
ContactGary Fingerman
CorrespondentFloyd G Larson
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-13
Decision Date2020-07-22

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