Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Drive
Libertyville,  IL  60048
Applicant Contact Albert Zickmann
Correspondent
Trisler Consulting, dba
306 Turnberry Court
Lebanon,  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
-
-