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K Number
K250946
Device Name
Denture Base Resin DT20
Manufacturer
Hangzhou SHINING3D Dental Technology Co., Ltd.
Date Cleared
2025-03-31

(3 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K191497
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria in the format you requested, as it pertains to a medical device's AI/algorithm performance.

The document is a 510(k) premarket notification for a Denture Base Resin (a material used for making dentures). It focuses on:

  • Substantial Equivalence: Comparing the new resin to an existing predicate resin based on material composition, intended use, manufacturing process, and various performance and biocompatibility tests for dental materials.
  • Non-Clinical Performance Tests: These tests are for the physical and biological properties of the resin material itself, such as mechanical properties according to ISO 20795-1, color stability according to ISO 7491, biocompatibility according to ISO 10993-1 and ISO 7405, and shelf-life.
  • No Clinical Study: The document explicitly states, "No clinical study is included in this submission."

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/algorithm, nor can I answer questions about sample sizes for test sets, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text which describes a physical dental material, not an AI medical device.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.