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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bracket, metal, orthodontic
510(k) Number K922499
Device Name REFLECTIONS - CERAMIC DENTAL BRACKET
Applicant
CDB CORP.
3625 HIGHWAY 421 NORTH
WILMINGTON,  NC  28401
Applicant Contact SYLVIA C JOYE
Correspondent
CDB CORP.
3625 HIGHWAY 421 NORTH
WILMINGTON,  NC  28401
Correspondent Contact SYLVIA C JOYE
Regulation Number872.5410
Classification Product Code
EJF  
Date Received05/27/1992
Decision Date 07/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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