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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 K232653
Device Name Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
Applicant
Blue Sky Bio, LLC
800 Liberty Dr.
Libertyville,  IL  60048
Applicant Contact Albert Zickmann
Correspondent
Trisler Consulting, Dba
306 Turnberry Court
Lebannon,  IN  46052
Correspondent Contact Patsy J Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
PNN  
Date Received08/31/2023
Decision Date 04/03/2024
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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