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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 K924132
Device Name E.Z. TEMEP, TEMPORARY FILLING MATERIAL
Applicant
Cosmedent, Inc.
5419 N. Sheridan Rd.
Chicago,  IL  60640
Applicant Contact MICHAEL O'MALLEY
Correspondent
Cosmedent, Inc.
5419 N. Sheridan Rd.
Chicago,  IL  60640
Correspondent Contact MICHAEL O'MALLEY
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/17/1992
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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