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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K980799
Device Name HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) 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 Number872.3770
Classification Product Code
EBG  
Date Received03/02/1998
Decision Date 10/28/1998
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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