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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 K904034
Device Name TEMPORARY DENTAL CEMENT
Applicant
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ANAND AKERKAR
Correspondent
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ANAND AKERKAR
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/31/1990
Decision Date 12/27/1990
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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