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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K221845
Device Name Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
Applicant
Blue Sky Bio, LLC
800 Liberty Dr.
Libertyville,  IL  60048
Applicant Contact Albert Zickmann
Correspondent
Bqc Consulting, LLC
24341 Barbados Dr.
Dana Point,  CA  92629
Correspondent Contact Nevine Erian
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
PNN  
Date Received06/24/2022
Decision Date 02/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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