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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mercury
510(k) Number K093587
Device Name DENTAL MERCURY
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 Number872.3070
Classification Product Code
ELY  
Date Received11/19/2009
Decision Date 01/21/2010
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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