Blue Sky Bio TAD

Implant, Endosseous, Orthodontic

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 Tad.

Pre-market Notification Details

Device IDK201919
510k NumberK201919
Device Name:Blue Sky Bio TAD
ClassificationImplant, Endosseous, Orthodontic
Applicant Blue Sky Bio, LLC. 800 Liberty Drive Libertyville,  IL  60048
ContactSharon Nichols
CorrespondentJuan Tezak
Compliance 4 Devices 118 W Prive Cr. Delray Beach,  FL  33445
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-10
Decision Date2020-12-17

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