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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 K030727
Device Name POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT
Applicant
Healex Products, Inc.
243 Elmwood Ave.
Providence,  RI  02907
Applicant Contact MILTON HODOSH
Correspondent
Healex Products, Inc.
243 Elmwood Ave.
Providence,  RI  02907
Correspondent Contact MILTON HODOSH
Regulation Number872.3275
Classification Product Code
EMA  
Date Received03/07/2003
Decision Date 06/05/2003
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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