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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K102252
Device Name DMP PIT & FISSURE SEALANT
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 Number872.3765
Classification Product Code
EBC  
Date Received08/10/2010
Decision Date 12/03/2010
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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