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TERA HARZ II is intended as an indirect restorative for both anterior restorations, including occlusal surfaces.
The TERA HARZ II 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 II 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 II is a light-cured, methacylate 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 dcclusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays, and veneers. Methacrylate based resin is well known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical and biocompatible properties.
The TERA HARZ II 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/B1/B2/B3/C1/C2/C3/D1/D2/D3/OM1/OM2/OM3/M4. 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 100um 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 II can be used in combination with all lasers and DLP based 3D printers which support dental materials. TERA HARZ II is a resin for the generative production of longterm temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ II is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ II 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 stereo-lithographic 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.
These fabrications of TERA HARZ II 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 II, 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for TERA HARZ II:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a dental material, and its performance is evaluated against the international standard ISO 10477:2020: Dentistry - Polymer-based crown and veneering materials. The key performance characteristics and their acceptance criteria (as per ISO 10477:2020) and reported performance are:
| Acceptance Criteria (ISO 10477:2020) | Reported Device Performance (TERA HARZ II) |
|---|---|
| Depth of Cure: Bottom surface shall be not less than 70% of the hardness of top surface | Avg. 91.3% |
| Flexural Strength: ≥ 50 MPa | Avg. 125.5 MPa |
| Water Sorption: ≤ 40 µg/mm³ | Avg. 22.03 µg/mm³ |
| Solubility: ≤ 7.5 µg/mm³ | Avg. 0.12 µg/mm³ |
| Shade consistency: No difference in color from different batches observed | No difference observed |
| Color stability: No color change after aging treatments detected | No color change detected |
| Biocompatibility: In accordance with ISO 10993-1, ISO 7405, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11 | Meets all specified ISO standards |
| Manufacturing Validation: All translational measurements within 0.150 mm of target input value | All translational measurements within 0.150 mm of target input value |
| Manufacturing Validation (Flexural Strength for Optimal Output Condition): ≥ 50 MPa | All specimens ≥ 50 MPa for optimal output condition |
| Manufacturing Validation (Material Reuse): No problem in effective outputs for repeated material output up to 6 times | Confirmed no problem for repeated material output up to 6 times |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for each specific test (e.g., number of specimens for flexural strength, water sorption tests). However, it implies multiple specimens were tested for each characteristic. The data provenance is not explicitly mentioned as retrospective or prospective or specific country of origin, but it is implied to be laboratory-based bench testing conducted by the manufacturer or a third-party for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of device and testing described. The "ground truth" for this device's performance is established by adherence to recognized international standards (ISO 10477:2020 and ISO 10993 series). The standards themselves are developed by expert committees, but there isn't a "test set" requiring individual expert adjudication for ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. The performance is measured against objective, quantitative criteria defined by international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI-assisted interpretation, where human readers interact with the device's output. TERA HARZ II is a dental restorative material, and its effectiveness is determined by its physical and chemical properties and biocompatibility, not by human interpretation of its output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is also not applicable in the typical sense. TERA HARZ II is a material, not a standalone algorithm. Its performance is measured directly through bench testing of the material itself. The manufacturing process does involve CAD/CAM systems and 3D printers, which are "standalone" in their function, but the performance evaluation focuses on the resulting material.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's performance is established international consensus standards for dental materials, specifically ISO 10477:2020 and a battery of ISO 10993 standards for biocompatibility. These standards define the acceptable range for various physical, mechanical, and biological properties.
8. The Sample Size for the Training Set
Not applicable. TERA HARZ II is a material, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this 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.