(1 days)
TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e, all second molars). Utilizing a series of increments, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended exclusively for professional dental work. Fabrication of aligner with TERA HARZ CLEAR requires an additive manufacturing system (AMS) that includes compatible with the following :
Design:
Scanner 3Shape A/S TRIOS 3 Basic
Design software 3Shape A/S 3Shape Ortho System™
Printing:
3D Printer UNIZ SLASH 2
UNIZ Nbee
SprintRay Inc. SprintRay Pro 95
Post-Curing:
Post-cure unit CureM U102H
Tera Harz Cure THC
TERA HARZ CLEAR is a series of clear aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. TERA HARZ CLEAR have 3 models : TC-85DAC, TR-07, TA-28. This series of aligner is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars) by moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. This series of aligner is worn for approximately 1 week of 20 to 22 hours per day after (However, there are to be removed for eating and for cleaning) which it is replaced by the next stage aligners and are designed to be used in a sequence. This is repeated for duration as prescribed by the dental clinician. TERA HARZ CLEAR is a light-cured, methacrylate-based resin commonly can used in additive manufacturing for the production of dental structures such as sequential aligners. TERA HARZ CLEAR has stored in a black 1,000 g of HDPE bottle. It contains materials with colors of yellowish. This device is a liquid photo-curable material that is polymerized by UV laser at 405412 nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395405 nm) by the photo-initiator contained in the resin. It is typically 100 um in thickness and is output at a resolution of 40 to 90 um on the x, y axis, and it is possible to produce threedimensional printed matter by curing lamination step by step a thickness of 100 um. However, scanner, design software, 3D printer and post-cure unit are not included with the device. These fabrications of TERA HARZ CLEAR are beginning with the dental clinician prescribing aligners to treat a patient's malocclusion, and decision to use methacrylate- based resins is made by the dental clinician. TERA HARZ CLEAR, an orthodontic appliance such as sequential aligner, 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 listed with Intraoral scanner under FDA Classification Product Code NOF, regulation872.3661. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate aligners. Commonly used standard dental software is used by dental professionals to virtually design a sequential aligner and generate an industrystandard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Ortho System™ by 3Shape A/S (K180941). The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470. This software is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of sequential aligners based on 3D scanned orthodontic models. Once dental clinic manufacturing unit receive the data that *.stl CAD files of the treatment plan the 3D printer begins additive manufacturing. The dental clinician generates sequential 3D printed models replicating the approved treatment plan. The sequential aligner is 3D printed and cured in a post-cure unit. The fabricated aligners are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the sequential aligners areprovides them to the patient the confirming fit and design.
The provided text describes the regulatory clearance of a dental device, "TERA HARZ CLEAR," an orthodontic plastic bracket (sequential aligner), by the FDA. The document focuses on demonstrating substantial equivalence to a predicate device, K180107 (Blue Sky Bio Aligner).
The information provided is primarily related to bench testing of material properties, rather than performance of an AI/ML algorithm or a multi-reader, multi-case study. Therefore, many of the requested points regarding AI/ML performance, ground truth establishment for AI models, and human reader studies (MRMC) are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are primarily derived from the ISO 20795-2:2013 standard, "Dentistry - Base Polymers - Part 2: Orthodontic base polymers." The device performance is compared to these criteria and the predicate device.
| Performance Metric | Acceptance Criteria (ISO 20795-2:2013) | Predicate Device (K180107) Performance | TERA HARZ CLEAR (Subject Device) Performance | Device Meets Criteria? |
|---|---|---|---|---|
| Ultimate Flexural Strength | ≥ 50 MPa | Avg. 51.7 MPa | TC-85DAC: Avg. 58.04 MPa | |
| TA-28: Avg. 70.26 MPa | ||||
| TR-07: Avg. 75.74 MPa | Yes | |||
| Flexural Modulus | ≥ 1500 MPa | Avg. 1560 MPa | TC-85DAC: Avg. 1575 MPa | |
| TA-28: Avg. 1849 MPa | ||||
| TR-07: Avg. 1764 MPa | Yes | |||
| Solubility | ≤ 5 µg/mm³ | Avg. 1.67 µg/mm³ | TC-85DAC: Avg. 1.56 µg/mm³ | |
| TA-28: Avg. 1.30 µg/mm³ | ||||
| TR-07: Avg. 1.39 µg/mm³ | Yes | |||
| Water Sorption | ≤ 32 µg/mm³ | Avg. 17.51 µg/mm³ | TC-85DAC: Avg. 17.03 µg/mm³ | |
| TA-28: Avg. 16.41 µg/mm³ | ||||
| TR-07: Avg. 16.22 µg/mm³ | Yes | |||
| Precision | Standard deviation |
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.