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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 K992879
Device Name ECUSIT COMPOSITE REPAIR
Applicant
Dmg Hamburg
5 Whitcomb Ave.
Ayer,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
Dmg Hamburg
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/26/1999
Decision Date 11/09/1999
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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