BLUE SKY BIO DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

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 Dental Implant System.

Pre-market Notification Details

Device IDK073713
510k NumberK073713
Device Name:BLUE SKY BIO DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake,  IL  60030
ContactMichele Vovolka
CorrespondentMichele Vovolka
BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake,  IL  60030
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-31
Decision Date2008-03-28
Summary:summary

NIH GUDID Devices

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