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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K052779
Device Name BRECOMP
Applicant
Bredent-Products For the Dental Technician Laborat
Schwarzwaldstr. 11
Tuttlingen,  DE 78532
Applicant Contact MARKUS DENK
Correspondent
Bredent-Products For the Dental Technician Laborat
Schwarzwaldstr. 11
Tuttlingen,  DE 78532
Correspondent Contact MARKUS DENK
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/03/2005
Decision Date 12/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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