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510(k) Data Aggregation
K Number
K182759Device Name
BoniPlus Dental G-Mesh System
Manufacturer
Date Cleared
2020-07-29
(670 days)
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
MontJade Engineering Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
"BoniPlus" Dental G-Mesh System is the non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites.
Device Description
The "BoniPlus" Dental G-Mesh System is a non-absorbable titanium screen made of pure Titanium (ASTM F-67), that helps in bone neoformation. They come in many different lengths, widths and thicknesses.
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