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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K031721
Device Name COMPOSITE RESTORATION MATERIAL
Applicant
Milton Hodosh, M.D.
243 Elwood Ave.
Providence,  RI  02907
Applicant Contact MILTON HODOSH
Correspondent
Milton Hodosh, M.D.
243 Elwood Ave.
Providence,  RI  02907
Correspondent Contact MILTON HODOSH
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/03/2003
Decision Date 09/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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