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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 K253337
Device Name REGEN Bioactive Cement
Applicant
Inter-Med, Inc.
2200 S. St.
Racine,  WI  53404
Applicant Contact Alex Johnson
Correspondent
Inter-Med, Inc.
2200 S. St.
Racine,  WI  53404
Correspondent Contact Alex Johnson
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/30/2025
Decision Date 04/15/2026
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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