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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 K100062
Device Name INFILTRATION KIT
Applicant
Dmg USA, Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact PAMELA PAPINEAU
Correspondent
Dmg USA, Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact PAMELA PAPINEAU
Regulation Number872.3765
Classification Product Code
EBC  
Date Received01/11/2010
Decision Date 03/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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