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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 K102257
Device Name NANOCERAM- BRIGHT
Applicant
Dmp, Ltd.
Kalyvion Ave.
Markopoulo Industrial Zone
Markopoulo, Attiki,  GR 19003
Applicant Contact DIMITRIS PRANTSIDIS
Correspondent
Dmp, Ltd.
Kalyvion Ave.
Markopoulo Industrial Zone
Markopoulo, Attiki,  GR 19003
Correspondent Contact DIMITRIS PRANTSIDIS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/10/2010
Decision Date 11/19/2010
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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