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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K241457
Device Name Vista BC Putty
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 Number872.3820
Classification Product Code
KIF  
Date Received05/23/2024
Decision Date 08/28/2024
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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