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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K102836
Device Name BONASIL A+ IMPRESSION MATERIALS
Applicant
Dmp, Ltd.
2nd Km Kalyvion Ave.
Markopoulo Industrial Zone
Markopoulo,  GR 19003
Applicant Contact DIMITRIS PRANTSIDIS
Correspondent
Dmp, Ltd.
2nd Km Kalyvion Ave.
Markopoulo Industrial Zone
Markopoulo,  GR 19003
Correspondent Contact DIMITRIS PRANTSIDIS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received09/29/2010
Decision Date 01/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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