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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bone grafting material, animal source
510(k) Number K193212
Device Name DSM Biomedical Dental Bone Graft Plus
DSM Biomedical
735 Pennsylvania Drive
Exton,  PA  19431
Applicant Contact Susan Pileggi
DSM Biomedical
735 Pennsylvania Drive
Exton,  PA  19431
Correspondent Contact Susan Pileggi
Regulation Number872.3930
Classification Product Code
Date Received11/21/2019
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No