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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name agent, tooth bonding, resin
510(k) Number K041960
Device Name COMPOSITE/COMPOMER REPAIR KIT
Applicant
DMG USA, INC.
414 SOUTH STATE ST.
DOVER,  DE  19901
Applicant Contact PAMELA PAPINEAU
Correspondent
DMG USA, INC.
414 SOUTH STATE ST.
DOVER,  DE  19901
Correspondent Contact PAMELA PAPINEAU
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EBF  
Date Received07/21/2004
Decision Date 08/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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