Blue Sky Bio CAD-CAM Abutments

Abutment, Implant, Dental, Endosseous

Blue Sky Bio, LLC

The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Blue Sky Bio Cad-cam Abutments.

Pre-market Notification Details

Device IDK202026
510k NumberK202026
Device Name:Blue Sky Bio CAD-CAM Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Blue Sky Bio, LLC 800 Liberty Drive Libertyville,  IL  60048
ContactMichele Kupcso
CorrespondentKevin A. Thomas
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-22
Decision Date2020-12-18

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