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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 K191823
Device Name Clear-Aligners
Applicant
CDB Corporation
9201 Industrial Blvd
Leland,  NC  28451
Applicant Contact Leah M. Lehman
Correspondent
CDB Corporation
9201 Industrial Blvd
Leland,  NC  28451
Correspondent Contact Leah M. Lehman
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/08/2019
Decision Date 12/20/2019
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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