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510(k) Data Aggregation
K Number
K243103Device Name
Denture Base
Manufacturer
Riton 3D Technology Co., Ltd
Date Cleared
2024-12-23
(84 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Riton 3D 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 and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Device Description
Fabrication of dental prosthetics with Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
The Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
Denture Base resin is intended exclusively for professional dental work.
Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
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