(1 days)
The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.
The TERA HARZ DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures). Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, and biocompatible properties. The TERA HARZ DENTURE is made from methacrylate-based resins. It is stored in a black 1,000g HDPE bottle. This resin is a liquid photopolymer material that is polymerized by a ultraviolet (UV) laser at 405412 nm. The resin can be used to create customized removable full and partial dentures with a 3D printer cured by UV light. The UV curable liquid resin is cured at a specific wavelength (395405 nm) by the photo-initiator contained in the resin. The process parameters of the 3D printer affect the quality of the 3D printed objects. The printer equipment should be set to a resolution of 40 to 90 um on the x,y axis (horizontal resolution) and 100 µm on the z axis (vertical resolution). The TERA HARZ DENTURE should be used with a specific 3D printer that uses a UV light source and produces 3D printed objects with layer thickness of 100 um. The TERA HARZ DENTURE does not come with a scanner, design software, 3D printer, or post-cure unit. The TERA HARZ DENTURE can be used to manufacture customized removable full and partial dentures using compatible equipment.
The provided text describes the regulatory filing for the Tera Harz Denture, a light-curable resin for dental prosthetics. This document primarily focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study of an AI-powered diagnostic device. Therefore, much of the requested information regarding AI study design (e.g., sample size for AI test sets, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this submission.
However, I can extract the acceptance criteria and performance data for the non-clinical performance testing of the dental resin itself, as this is the "device" in question and its performance is being proven against established standards.
Here's a summary based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TERA HARZ DENTURE are based on the ISO 20795-1:2013 standard for dentistry — base polymers. The performance data is from non-clinical bench tests.
| Performance Characteristic | Acceptance Criteria (from ISO 20795-1:2013) | Reported Device Performance (TERA HARZ DENTURE Test Results) |
|---|---|---|
| Flexural strength | > 65 MPa | Average 94.43 MPa |
| Flexural modulus | > 2,000 MPa | Average 2545.32 MPa |
| Water absorption | ≤ 32 µg/mm³ | Average 10.30 µg/mm³ |
| Water solubility | ≤ 1.6 µg/mm³ | Average 1.22 µg/mm³ |
Additional performance tests were conducted, and the results met standard criteria, but specific numerical acceptance criteria and reported values for those tests (e.g., visual inspection, capacity, package integrity, surface characteristics, shape capability, porosity, translucency, color, color stability, bonding between resin teeth, total fracture work, maximum stress intensity factor) are not explicitly detailed with thresholds and results in the provided tables.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests: The document does not specify the exact sample size (number of specimens) used for each performance test (flexural strength, water sorption, etc.). It only refers to "test specimens."
- Data Provenance: The data provenance is from non-clinical bench tests conducted by Graphy Inc., likely in the Republic of Korea (where Graphy Inc. and SMB Korea are located). The study type is experimental bench testing, not retrospective or prospective patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission is for a material (dental resin) and its manufacturing process, not an AI diagnostic device requiring expert interpretation of medical images or data. Ground truth is established through adherence to international standards and validated laboratory testing procedures for material properties.
4. Adjudication Method for the Test Set
Not applicable for material property testing. The "ground truth" is measured objectively according to standardized laboratory methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device where human reader performance is evaluated.
6. Standalone Performance
The "standalone performance" refers to the non-clinical bench testing of the Tera Harz Denture material itself, without human interpretation as part of the performance evaluation. The results listed in the table above demonstrate its standalone performance against the ISO standards.
7. Type of Ground Truth Used
The ground truth used for the performance testing is international standard criteria (ISO 20795-1:2013) for dental base polymers, measured through objective laboratory tests.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set" in the computational sense. The "training" here refers to the development and formulation of the resin material and the optimization of its manufacturing process through empirical testing.
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no "training set" in the context of an AI algorithm. The development of the material and process relies on established chemical and engineering principles and iterative testing against performance specifications to achieve desired properties.
§ 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.