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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 K200005
Device Name Concinnity Aligners
Applicant
Drake Precision Dental Laboratory, Inc.
8510 Crown Crescent Ct.
Charlotte,  NC  28227
Applicant Contact Robert Savage
Correspondent
Bdra Consulting, LLC
1 Clearwater Court
Damascus,  MD  20872
Correspondent Contact Srinagesh Koushik
Regulation Number872.5470
Classification Product Code
NXC  
Date Received01/02/2020
Decision Date 11/09/2020
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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