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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 K240660
Device Name Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
Applicant
Kulzer, LLC
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact Harmon Lucas
Correspondent
Kulzer, LLC
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact Lucas Harmon
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBD  
Date Received03/08/2024
Decision Date 09/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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