(293 days)
TERA HARZ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces.
The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.
Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
The TERA HARZ 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 physical-chemical, mechanical and biocompatible properties.
The TERA HARZ is made by Methacrylate-based resins. It has stored in a black 1,000g of HDPE bottle. It contains materials with shade A1/A2/A3. This resin is a liquid photopolymer material that is polymerized by UV laser at 405412nm. the resin can be used to create a customized artificial permanent tooth model with a 3d printer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 100μm in layer thickness, and is output at a resolution of 40 to 90μm on the x, y axis. This device should use specific 3D Printer equipment using UV light source, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100μm.
However, scanner, design software, 3D printer and post-cure unit are not included with the device.
TERA HARZ can be used in combination with specified lasers and DLP based 3D printers which support dental materials. TERA HARZ is a resin for the generative production of permanent or temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ is successfully tested for biocompatibility, certainly meets all mechanical and application demands. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing.
The material can be used for build processes with layer thicknesses from 25 up to 100 um. After printing, the printed product is recommended to use a UV-light curing for final polymerization.
3D printer is not included with the device.
These fabrications of TERA HARZ are beginning with the dental clinician prescribing indirect restorative to treat a patient's both anterior restorations, including occlusal surfaces, and decision to use methacrylate-based resins is made by the dental clinician. TERA HARZ, a permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations, is manufactured in a 3D printer that is compatible.
The dental clinician can generate a digital file by scanning the patient's mouth directly using approved Intraoral scanner software. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate permanent or temporary restorations. Commonly used standard dental software is used by dental professionals to virtually design a restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3D Scanner by 3Shape A/S (510(K) Exempt). The specialized prosthetic treatment planning software has a establishment registration for the intended use under FDA Classification Product Code NOF, regulation 872.3661. This software is used for management of 3D scanned prosthetic models, prosthetic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned prosthetic models, virtual planning of prosthetic treatments by simulating tooth movements, and design of permanent or temporary restorations based on 3D scanned prosthetic models.
Once dental clinic manufacturing unit receive the data that *.stl CAD files of crown and bridge the 3D printer begins additive manufacturing. The dental clinician (e.g., dentist) generates sequential 3D printed models replicating the approved treatment plan. The permanent or temporary restorations is 3D printed and cured in a post-curing unit. The fabricated permanent or temporary restorations are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the permanent or temporary restorations are provides them to the patient the confirming fit and design.
This document is a 510(k) summary for a dental resin material, TERA HARZ. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study to prove acceptance criteria for an AI/ML powered device.
Therefore, most of the requested information regarding acceptance criteria and a study proving a device meets these criteria is not present in the provided text, as this document pertains to a material for dental restorations, not an AI-powered diagnostic or assistive tool. Specifically, there is no mention of AI, machine learning, expert readers, ground truth establishment for a test set, MRMC studies, or standalone algorithm performance.
However, I can extract information related to the physical and chemical performance criteria for this dental material:
1. A table of acceptance criteria and the reported device performance:
The document compares the performance of TERA HARZ (Subject Device) with two predicate devices (K201668 and K193553). While explicit "acceptance criteria" are not listed in a dedicated table, the comparisons imply the criteria the subject device aims to meet or exceed based on the predicate devices and relevant ISO standards.
| Characteristic | Acceptance Criterion (Implied from Predicate/ISO) | Reported TERA HARZ Performance | Discussion/Compliance |
|---|---|---|---|
| Flexural Strength | ≥ 100 MPa (ISO 4049) and ≥ 50 MPa (ISO 10477) | Avg. 148.73 MPa | Meets requirements from ISO 4049:2019 and ISO 14077:2018. "Both devices meet requirements" |
| Water Sorption | ≤ 40 µg/mm³ | Avg. 13.03 µg/mm³ | Meets acceptance criteria. |
| Solubility | ≤ 7.5 µg/mm³ | Avg. 1.00 µg/mm³ | Meets requirements from ISO 4049:2019 and ISO 14077:2018. "Both devices meet requirements" |
| Biocompatibility | Compliant with ISO 10993 series, ISO 7405 | Compliant | Tested and shown to be compliant. |
| Manufacturing Validation (Translational Measurements) | Within 0.150 mm of target input value | All within 0.150 mm | Met pre-established acceptance criteria. |
| Flexural strength of outputted TERA HARZ (manufacturing validation) | > 50 MPa (for different output conditions) | All specimens > 50 MPa | Optimal output condition confirmed. |
2. Sample size used for the test set and the data provenance:
- Manufacturing Validation: For translational measurements, "All translational measurements" implies multiple measurements were taken, but a specific number / sample size is not stated.
- Flexural Strength, Water Sorption, Solubility: Sample sizes are not explicitly stated for these tests, but they are typically conducted on a set number of specimens as per ISO standards.
- Data Provenance: The tests were conducted internally by Graphy Inc. or by independent 3rd parties as part of the manufacturing validation and performance testing process for the TERA HARZ product. The document does not specify country of origin for the test data (beyond the applicant being based in Republic of Korea). The data is generated from testing the physical properties of the manufactured resin, so it is "prospective" in the sense that the testing was performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a dental material, not an AI/ML-powered diagnostic device requiring expert annotation for a test set. Ground truth relates to physical property measurements, not clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device. Physical property measurements do not involve adjudication by multiple experts in the same way clinical image interpretations do.
5. 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 is not an AI/ML device, and no MRMC study was conducted. The document explicitly states: "No clinical data is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance tests (Flexural Strength, Water Sorption, Solubility) and manufacturing validation is based on physical and chemical measurements obtained through standardized laboratory testing methods (e.g., ISO 4049, ISO 10477) using calibrated equipment. For biocompatibility, the "ground truth" is compliance with ISO standards (e.g., ISO 10993 series).
8. The sample size for the training set:
- Not applicable. This device is a material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML algorithm, this information is not relevant.
In summary, the provided document is a regulatory submission for a dental resin material, focusing on its physical, chemical, and biocompatibility properties to demonstrate substantial equivalence to existing predicate devices. It does not contain information related to the development or validation of an AI/ML-powered medical 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.