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510(k) Data Aggregation
K Number
K102208Device Name
NANOGEN
Manufacturer
Date Cleared
2011-05-06
(274 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
ORTHOGEN, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NanoGen is indicated for use in the following ways; by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect; and, to provide a resorbable barrier over other bone graft materials.
Device Description
NanoGen is a mixture of particles composed of densely packed grains of nanocrystalline calcium sulfate and medical grade calcium sulfate hemihydrate powder. The particles range from 400 - 850 microns in size. The particles of nanocrystalline calcium sulfate are purely synthetic and are manufactured from medical grade calcium sulfate hemihydrate through a proprietary process. Because of its unique structure, NanoGen undergoes controlled, slower degradation as compared to traditional calcium sulfate.
NanoGen is designed to set-up in vivo and may be used either alone or mixed with DFDBA (demineralized freeze-dried bone allograft) or autogenous bone in bone in bone regenerative procedures. It is mixed with small amounts of normal saline to produce a putty-like paste and is then applied to the bone defects. Set NanoGen dissolves with time. The calcium present in NanoGen is believed to contribute to the mineralization of newly regenerated bone.
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