(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; SprintRay Inc., SprintRay Pro 95
Post-Curing:
Post-cure unit: CureM, U102H
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.
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 µm on the x, y axis, and it is possible to produce three-dimensional 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 methacrylatebased 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, regulation 872.3661.
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 industry-standard "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 are provides them to the patient the confirming fit and design.
This document describes the premarket notification for the "TERA HARZ CLEAR" sequential aligner and its substantial equivalence determination by the FDA. The information provided focuses on the device's technical characteristics and performance testing against a predicate device and relevant standards.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study
The acceptance criteria are generally based on the ISO 20795-2:2013 standard for "Dentistry - Base Polymers - Part 2: Orthodontic base polymers," and comparisons to a predicate device (Blue Sky Bio Aligner, K180107).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria | TERA HARZ CLEAR (UNIZ Slash 2) Performance | TERA HARZ CLEAR (SprintRay PRO 95) Performance | Predicate Device (Blue Sky Bio Aligner) Performance |
|---|---|---|---|---|
| Physical Properties | ||||
| Surface characteristics | smooth, hard, and glossy | smooth, hard and glossy | smooth, hard and glossy | smooth, hard and glossy |
| Shape capability | edges are reproduced | edges are reproduced | edges are reproduced | edges are reproduced |
| Colour | transparently without changing | transparently without changing | transparently without changing | transparently without changing |
| Freedom from porosity | no porosity | no porosity | no porosity | no porosity |
| Ultimate Flexural Strength | ≥5 MPa | Avg. 5.92 MPa | Avg. 6.02 MPa | Avg. 5.17 MPa |
| Flexural modulus | ≥50 MPa | Avg. 69.10 MPa | Avg. 72.38 MPa | Avg. 56.26 MPa |
| Solubility | ≤5 µg/mm³ | Avg. 1.54 µg/mm³ | Avg. 1.56 µg/mm³ | Avg. 1.67 µg/mm³ |
| Water sorption | ≤32 µg/mm³ | Avg. 17.45 µg/mm³ | Avg. 17.03 µg/mm³ | Avg. 17.51 µg/mm³ |
| Precision | standard deviation less than 0.150 mm (implicitly) | Uniz: Avg.0.072/mm (specific values provided) | SprintRay: Avg.0.065/mm (specific values provided) | Avg. 0.122/mm (specific values provided) |
| Appearance | No foreign materials, contaminations, or defects | No evidence of foreign materials, contaminations, | No evidence of foreign materials, contaminations, | No evidence of foreign materials, contaminations, |
| or any other defects | or any other defects | or any other defects | ||
| Biocompatibility | ||||
| Biocompatibility | Biocompatible according to ISO 10993-1 | Biocompatible according to ISO 10993-1 | Biocompatible according to ISO 10993-1 | Predicate did not perform testing (510k clearance) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For physical properties testing (such as Ultimate Flexural Strength, Flexural Modulus, Solubility, Water Sorption, Surface characteristics, Shape capability, Colour, Freedom from porosity, and Precision), 5 samples of the "TERA HARZ CLEAR" device were used for each test. These samples were from the same lot and tested using two different 3D printers (UNIZ Slash 2 and SprintRay Pro 95).
- Data Provenance: The document does not explicitly state the country of origin for the test data but indicates that the submitting company, Graphy Inc., is located in Seoul, Republic of Korea. The testing itself involved comparisons to a legally marketed predicate device (Blue Sky Bio Aligner) and adherence to international standards (ISO 20795-2:2013). The study appears to be prospective bench testing performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical evaluation. The ground truth for the physical and mechanical properties was established by adherence to the ISO 20795-2:2013 standard and direct comparison against a legally marketed predicate device's performance data.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the study primarily involved bench testing of physical and mechanical properties against a standard and a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or reported in this document. The device is a physical product (sequential aligner), and the evaluation focuses on its material properties and manufacturing validation rather than diagnostic performance or human-in-the-loop effectiveness.
6. Standalone Performance (Algorithm Only)
This section is not applicable as the "TERA HARZ CLEAR" is a physical medical device (sequential aligner), not a software algorithm or AI-powered diagnostic tool. The document describes the design software and 3D printing systems used in its fabrication, but the device itself is the physical aligner.
7. Type of Ground Truth Used
The ground truth for the device's performance was primarily based on:
- International Standard Requirements: ISO 20795-2:2013.
- Predicate Device Performance: Direct comparison of physical and mechanical properties with a legally marketed predicate device (Blue Sky Bio Aligner, K180107).
- Manufacturing Validation: Verifying that manufactured devices meet predefined dimensional tolerances (0.150 mm of the target input value) using independent software and digital calipers.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI. Since this is a physical medical device and not an AI/software product, the concept of a training set as typically understood in AI/ML studies is not applicable.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
§ 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.