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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bracket, ceramic, orthodontic
510(k) Number K160957
Device Name CDB Self Ligating Bracket 8F
Applicant
CDB CORPORATION
9201 INDUSTRIAL BOULEVARD, NE
LELAND,  NC  28451
Applicant Contact YANNIRE THOMPSON
Correspondent
CDB CORPORATION
9201 INDUSTRIAL BOULEVARD, NE
LELAND,  NC  28451
Correspondent Contact YANNIRE THOMPSON
Regulation Number872.5470
Classification Product Code
NJM  
Date Received04/05/2016
Decision Date 09/27/2016
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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