(385 days)
The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restoration of C&B NFH Hybrid requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
The C&B NFH Hybrid is a light-cured, methacrylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physicalchemical, mechanical and biocompatible properties.
This document is a 510(k) Premarket Notification from the FDA for a dental resin material named "C&B NFH Hybrid." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria in a clinical study involving experts or human readers with AI assistance.
Therefore, many of the requested details about acceptance criteria and a study proving device meets them are not applicable in this context, as this document pertains to a material's physical and chemical properties and biocompatibility for substantial equivalence, rather than an AI-powered diagnostic device or a device requiring a multi-reader, multi-case study.
However, I can extract the acceptance criteria and reported performance for the physical properties of the dental resin, which are relevant to its substantial equivalence.
Acceptance Criteria and Reported Device Performance (Physical Properties of Dental Resin)
| Acceptance Criteria (Standard) | Reported Device Performance (C&B NFH Hybrid) |
|---|---|
| Flexural Strength (≥50 MPa; ISO 10477) | Avg. 114.32 MPa |
| Flexural Strength (≥100 MPa; ISO 4049) | Avg. 114.32 MPa |
| Water sorption (≤40 µg/mm³) | Avg. 31.32 µg/mm³ |
| Solubility (≤7.5 µg/mm³) | Avg. 5.59 µg/mm³ |
Study Information (Based on the document provided):
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Sample size used for the test set and the data provenance: Not explicitly stated with specific numbers of samples for each test (e.g., how many specimens were tested for flexural strength). The data provenance is from non-clinical performance testing conducted by the manufacturer, ARUM DENTISTRY Co., Ltd., likely in a laboratory setting. This is not patient-specific or clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical property testing of a material, "ground truth" is typically established by standardized testing methods and measurements, not by expert interpretation in the medical sense.
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Adjudication method for the test set: Not applicable. Standardized laboratory testing methods do not involve adjudication in the way clinical studies with human observers do.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental material, not an AI-powered diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material, not an algorithm.
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The type of ground truth used: Standardized laboratory measurements according to ISO 10477:2020 and ISO 4049:2013 for physical properties (flexural strength, water sorption, solubility). For biocompatibility, compliance was shown with ISO 7405, ISO 10993-1, -5, -10, -11, -12, and -23.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires training data.
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How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (Non-Clinical Performance Data) from the document:
The device did not undergo a "study" in the clinical sense with human readers or AI. Instead, the manufacturer provided Non-Clinical Performance Data to support the substantial equivalence determination for the "C&B NFH Hybrid" dental resin.
The data presented focuses on:
- Physical Property Testing: The device was tested for flexural strength, water sorption, and solubility. The reported values demonstrate that the device meets or exceeds the requirements set by the international standards ISO 10477:2020 ("Dentistry - Polymer-based crown and veneering materials") and ISO 4049:2013 ("Dentistry - Polymer-based restorative materials").
- Biocompatibility: The C&B NFH Hybrid material (Dimethacrylate based resins) was shown to be compliant with a series of ISO 10993 and ISO 7405 standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
- Shelf-Life: Accelerated aging tests in accordance with ASTM F1980 validated a 2-year shelf-life.
The purpose of these tests was to demonstrate that the C&B NFH Hybrid has similar safety and effectiveness characteristics to its predicate device (K202846, TERA HARZ by Graphy Inc.) and meets established performance standards for dental materials. The conclusion is that the subject device is substantially equivalent to the predicate device.
§ 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.