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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K905582
Device Name POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND
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 Number872.3765
Classification Product Code
EBC  
Date Received12/12/1990
Decision Date 04/29/1991
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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