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510(k) Data Aggregation
K Number
K233125Device Name
Zirconia Block
Manufacturer
Date Cleared
2024-01-12
(107 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou IVISTA Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, for jacket facing, veneers. All Blocks are processed through dental laboratories or by dental professionals.
Device Description
Zirconia ceramic block is made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental appliance/prosthesis (e.g., removable dentures, for jacket facing, veneers) for patient use. It is used to removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
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