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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K212785
Device Name Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
Applicant
Blue Sky Bio, LLC
800 Liberty Dr.
Libertyville,  IL  60048
Applicant Contact Albert Zickmann
Correspondent
Blue Sky Bio, LLC
800 Liberty Dr.
Libertyville,  IL  60048
Correspondent Contact Albert Zickmann
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/01/2021
Decision Date 06/30/2022
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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