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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K974494
Device Name RENAMEL FLOWABLE COMPOSITE
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 Number872.3310
Classification Product Code
EBD  
Date Received11/28/1997
Decision Date 02/10/1998
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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