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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 K091702
Device Name CDB FLIP-SIDE-CLIP BRACKET
Applicant
CDB CORPORATION
9201 INDUSTRIAL BLVD.
LELAND,  NC  28451
Applicant Contact CHARLES VERNON
Correspondent
CDB CORPORATION
9201 INDUSTRIAL BLVD.
LELAND,  NC  28451
Correspondent Contact CHARLES VERNON
Regulation Number872.5470
Classification Product Code
NJM  
Date Received06/10/2009
Decision Date 08/07/2009
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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