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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 Street, Suite 102
Denton,  TX  76207
Applicant Contact Andrew Loch
Correspondent
Five Star Orthodontic Lab & Supply
2928 Metro Street, 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
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