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FDA 510(k)

DSM Biomedical Dental Bone Graft Plus

K-Number: K193212 · 2020-09-10

ApplicantDsm Biomedical
Decision Date2020-09-10
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DSM Biomedical Dental Bone Graft Plus is the device name listed in this FDA 510(k) record. The listed applicant is Dsm Biomedical. It received FDA 510(k) clearance on 2020-09-10 under 510(k) number K193212. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSM Biomedical Dental Bone Graft Plus?

DSM Biomedical Dental Bone Graft Plus is a medical device that received FDA 510(k) clearance on 2020-09-10. The listed applicant is Dsm Biomedical. The 510(k) number is K193212.

When did DSM Biomedical Dental Bone Graft Plus receive FDA 510(k) clearance?

DSM Biomedical Dental Bone Graft Plus received FDA 510(k) clearance on 2020-09-10, under 510(k) number K193212.

Who is the listed applicant for DSM Biomedical Dental Bone Graft Plus?

The FDA 510(k) record lists Dsm Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSM Biomedical Dental Bone Graft Plus?

The FDA product code for DSM Biomedical Dental Bone Graft Plus is NPM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07091448Biotivity A-C Membrane Socket Preservation StudyNOT_YET_RECRUITINGNCT07701473Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case SeriesNOT_YET_RECRUITINGNCT06533397The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor ElevationRECRUITINGNCT07057817The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb SalvageRECRUITINGNCT07381608Clinical and Patient-reported Outcomes of Guided Versus Freehand Harvesting Of Positioning of Autogenous Bone ShellsCOMPLETEDNCT07512011Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation ProcedureNOT_YET_RECRUITING

Other records listing Dsm Biomedical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230054DSM Biomedical Calcium Phosphate Cement

Related Devices (Code: NPM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613SwissGraft XGeistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLCK230305THE Graft CollagenPurgo Biologics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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