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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 K121915
Device Name BRIGHT RESTORATIVE MATERIALS
Original Applicant
DMP LTD
kalyvion avenue
markopoulo industrial zone
markopoulo, attiki,  GR 19003
Original Contact dimitris prantsidis
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBC  
Date Received07/02/2012
Decision Date 09/28/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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