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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K202026
Device Name Blue Sky Bio CAD-CAM Abutments
Applicant
Blue Sky Bio, LLC
800 Liberty Dr.
Libertyville,  IL  60048
Applicant Contact Michele Kupcso
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A. Thomas
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/22/2020
Decision Date 12/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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