DSM Biomedical Dental Bone Graft Plus

Bone Grafting Material, Animal Source

DSM Biomedical

The following data is part of a premarket notification filed by Dsm Biomedical with the FDA for Dsm Biomedical Dental Bone Graft Plus.

Pre-market Notification Details

Device IDK193212
510k NumberK193212
Device Name:DSM Biomedical Dental Bone Graft Plus
ClassificationBone Grafting Material, Animal Source
Applicant DSM Biomedical 735 Pennsylvania Drive Exton,  PA  19431
ContactSusan Pileggi
CorrespondentSusan Pileggi
DSM Biomedical 735 Pennsylvania Drive Exton,  PA  19431
Product CodeNPM  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-21
Decision Date2020-09-10

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