LogoFDA 510(k) Search
K Number
K202063
Device Name
TrusFIL Universal Composite Restorative
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2021-10-06

(436 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K083610
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TrusFIL Universal Composite Restorative is a visible light curing dental restorative material indicated for:

  • Direct anterior and posterior restorations (including occlusal surfaces);
  • Core Build-ups;
  • Splinting:
  • Indirect restorations including inlays, onlays and veneers.
Device Description

TrusFIL Universal Composite Restorative is a visible-light activated, restorative composite designed for use in anterior and posterior restorations. The principal organic components are mixtures of dental methacrylate resins (Bis-GMA, EBPADMA). The inorganic filler loading is about 54% by volume having particle size range of about 0.01 to 2 microns. It is packaged in syringes and single-dose capsules. Single-dose delivery is intended for single patient (single use) only to prevent cross-contamination between patients.

Available shades include opaque dentin shades, regular body shades and enamel shades. All shades are radiopaque.

AI/ML Overview

The provided document is a 510(k) summary for a dental composite restorative device (TrusFIL Universal Composite Restorative). It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain information about an AI/ML medical device. Therefore, it is not possible to describe acceptance criteria and a study proving an AI/ML device meets them, as requested in your prompt. The questions in your prompt (e.g., sample size for test set, number of experts, MRMC study, ground truth) are relevant to the evaluation of AI/ML devices, but this document pertains to a traditional dental material.

The data presented is primarily in-vitro bench testing of physical and chemical properties of the dental composite, not clinical performance for an AI/ML algorithm.

Therefore, I cannot fulfill your request as the provided text does not contain the necessary information about an AI/ML device and its performance study.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.