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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 Hwy. 421 N.
Wilmington,  NC  28401
Applicant Contact SYLVIA C JOYE
Correspondent
Cdb Corp.
3625 Hwy. 421 N.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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