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510(k) Data Aggregation
K Number
K240586Device Name
Additive Manufacturing Zirconia Customized Restoration
Manufacturer
Hangzhou Thales Medtech Co., Ltd.
Date Cleared
2024-10-03
(216 days)
Product Code
ELL, EIH
Regulation Number
872.3920Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Thales Medtech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.
The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown, Bridge, Veneer, Inlay) that will be cemented to a natural or artificial tooth abutment.
Device Description
Additive Manufacturing Zirconia Customized Restoration is an individualized dental restoration (Crown,Bridge,Veneer,Inlay) made from zirconia slurry.
Additive Manufacturing Zirconia Customized Restoration is intended to be a replacement for a natural tooth.After finalizing the Additive Manufacturing Zirconia Customized Restoration in the laboratory.t is cemented or bonded onto a tooth or artificial abutment, by a clinician,to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.
To achieve esthetic and required value and chroma of the surrounding natural teeth the Additive Manufacturing Zirconia Customized Restoration is suitable for cut-back(veneering) or stain and glaze techniques.
The design of the Additive Manufacturing Zirconia Customized Restoration is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using or supported third party CAD systems. Once the restoration is ordered, it is sent electronically to Hangzhou Thales Medtech Co., Ltd. for fabrication.
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