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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 K254063
Device Name iCEM Universal Plus
Applicant
Kulzer, LLC
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact Lucas Harmon
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number872.3275
Classification Product Code
EMA  
Date Received12/17/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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