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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K925207
Device Name GLASS IONOMER CEMENT
Applicant
Milton Hodosh, M.D.
243 Elwood Ave.
Providence,  RI  02907
Applicant Contact HODOSH, D.M.D
Correspondent
Milton Hodosh, M.D.
243 Elwood Ave.
Providence,  RI  02907
Correspondent Contact HODOSH, D.M.D
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/23/1992
Decision Date 07/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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