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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 K240714
Device Name Insure® Universal; Insure® Universal Automix
Applicant
Cosmedent, Inc.
401 N. Michigan Ave. Suite 2500
Chicago,  IL  60611
Applicant Contact Gary Chuven
Correspondent
Deltamed GmbH
Raiffeisenstr. 8a
Friedberg,  DE 61169
Correspondent Contact Michael Zimmermann
Regulation Number872.3275
Classification Product Code
EMA  
Date Received03/15/2024
Decision Date 07/24/2024
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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