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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K243910
Device Name Retraxil
Applicant
Kulzer, LLC
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact Lucas Harmon
Correspondent
Kulzer, LLC
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact Lucas Harmon
Classification Product Code
MVL  
Date Received12/19/2024
Decision Date 09/24/2025
Decision Substantially Equivalent (SESE)
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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