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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K260783
Device Name Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One
Applicant
Kulzer, LLC
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact Aiden Lane
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
EBC   LBH  
Date Received03/10/2026
Decision Date 03/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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