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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K082700
Device Name TEMPORARY COLD.V AND SELF-CURE DENTINE
Applicant
Major Prodotti Dentari S.P.A.
Via Luigi Einaudi 23
Monacalieri (Torino),  IT I-10024
Applicant Contact MONICA FUNAI
Correspondent
Major Prodotti Dentari S.P.A.
Via Luigi Einaudi 23
Monacalieri (Torino),  IT I-10024
Correspondent Contact MONICA FUNAI
Regulation Number872.3770
Classification Product Code
EBG  
Date Received09/15/2008
Decision Date 12/09/2008
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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