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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K862912
Device Name RENAMELIZE POLISHING PASTE
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 Number872.6030
Classification Product Code
EJR  
Date Received08/01/1986
Decision Date 08/12/1986
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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