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510(k) Data Aggregation
K Number
K250946Device Name
Denture Base Resin DT20
Manufacturer
Hangzhou SHINING3D Dental Technology Co., Ltd.
Date Cleared
2025-03-31
(3 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou SHINING3D Dental Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture base Resin requires a digital denture file, 3D printer and post-curing unit.
Device Description
Denture Base Resin is a liquid light-curable material. The product should be used in combination with the 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. The 3D printer and the post-curing unit of SHINING3D make use of a light source to polymerize the Denture Base Resin.
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