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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthodontic software
510(k) Number K212173
Device Name HDH Treatment Planning System
CDB Corporation
9201 Industrial Park Boulevard
Leland,  NC  28451
Applicant Contact Leah M Lehman
CDB Corporation
9201 Industrial Boulevard, NE
Leland,  NC  28451
Correspondent Contact Leah M Lehman
Regulation Number872.5470
Classification Product Code
Subsequent Product Code
Date Received07/12/2021
Decision Date 01/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No