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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 K210613
Device Name HIT Clear Aligner
Applicant
Cdb Corporation
9201 Industrial Park Blvd.
Leland,  NC  28451
Applicant Contact Leah M Lehman
Correspondent
Cdb Corporation
9201 Industrial Blvd., NE
Leland,  NC  28451
Correspondent Contact Leah M Lehman
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/01/2021
Decision Date 06/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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