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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 K182658
Device Name Bioliner
Applicant
Five Star Orthodontic Lab & Supply
2928 Metro St., Suite 102
Denton,  TX  76207
Applicant Contact Andrew Loch
Correspondent
Five Star Orthodontic Lab & Supply
2928 Metro St., Suite 102
Denton,  TX  76207
Correspondent Contact Andrew Loch
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/25/2018
Decision Date 06/19/2019
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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