(60 days)
Reon is a 3D printing resin used in dentistry for the fabrication of both temporary and permanent dental restorations, specifically crowns, bridges, inlays, onlays, and veneers.
Reon is a photopolymerizable, methacrylate-based composite resin used in dental CAD/CAM technology for the fabrication of dental prostheses. This resin is specifically designed for both temporary and permanent dental restorations, such as crowns, bridges, inlays, onlays, and veneers, utilizing 3D printing processes.
Reon is a light-curing methacrylate-based polymer resin used in the production of dental restorations through CAD/CAM technology at dental clinics. This resin is suitable for the 3D printing process of temporary and permanent dental restorations, especially crowns, bridges, inlays, onlays, and veneers.
Reon is made from a methacrylate-based resin and is stored in liquid form in Aluminum 1050A or 1070A bottles, with two different volumes (500 g/1,000 g) for each shade. To support a variety of shades, it offers four different options: Clear, A1, A2 and A3. This resin is cured using a UV (ultraviolet) laser with a wavelength of 405nm, activated by a specific photoinitiator at 405nm.
Reon is suitable for creating custom dental restorations using UV-curing 3D printers. It can be used under the following printing and curing conditions:
- Layer Thickness: 50 μm
- Resolution: X, Y axis resolution of 40-90 μm
- Printing Process: Compatible with DLP (Digital Light Processing) based 3D printers
- Post-Curing: Final polymerization is completed by additional UV curing after printing
Reon is compatible with UV-curing 3D printers and is primarily used with the following devices:
- 3D Printer: DLP-based 3D printers
- Software: CAD files (.stl) generated from dental software for printing
- Scanner Compatibility: Intraoral Scanner and 3D design software (e.g., 3Shape)
The clinical workflow for Reon is as follows:
- The dentist uses an intraoral scanner to scan the patient's mouth and create a CAD file.
- Based on the scan data, the restoration is designed using software.
- The designed STL file is used to print custom crowns, bridges, etc., with a 3D printer.
- The printed restoration undergoes additional UV curing in a post-curing device to complete the hardening process.
- The final restoration is then trimmed and polished to fit the patient's teeth before being provided to the patient.
Reon has passed biocompatibility testing and meets the necessary physical, chemical, and mechanical properties, making it suitable for use in dental restorations.
Please note that this product must be used in conjunction with a scanner, design software, and a 3D printer, which are not included with the product. Additionally, to achieve optimal performance, the UV curing process after printing is essential.
The provided text describes a 510(k) clearance for "Reon Dental Resin," a 3D printing resin for dental restorations. The information below focuses on the acceptance criteria and the study used to demonstrate substantial equivalence, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance:
The device's performance was evaluated against the standards outlined in ISO 10477:2020, "Dentistry – Polymer-based crown and veneering materials." The reported performance of the Reon device is compared to these acceptance criteria and the predicate device (Tera Harz II).
Table: Acceptance Criteria and Reported Device Performance for Reon Dental Resin
| Performance Metric | Acceptance Criteria (ISO 10477:2020) | Reon (Proposed Device) Performance | Tera Harz II (Predicate Device) Performance |
|---|---|---|---|
| Depth of Cure (%) | Not less than 70% of the hardness of the top surface | Avg. 90.0% | Avg. 91.3% |
| Flexural Strength | ≥ 50 MPa | Avg. 119.0 MPa | Avg. 125.5 MPa |
| Water Sorption | ≤ 40 μg/mm³ | Avg. 11.0 μg/mm³ | Avg. 22.03 μg/mm³ |
| Solubility | ≤ 7.5 μg/mm³ | Avg. 3.24 μg/mm³ | Avg. 0.12 μg/mm³ |
| Shade Consistency | No difference in color from different batches observed | No difference observed | No difference observed |
| Color Stability | No color change after aging treatments detected | No color change detected | No color change detected |
| Biocompatibility | Compliant with ISO 10993-1 | Compliant | Compliant |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set used for performance testing (Depth of Cure, Flexural Strength, Water Sorption, Solubility, Shade Consistency, Color Stability). However, it mentions that for "Manufacturing Validation," "the evaluation criteria of all the specimens were more than 50 MPa," implying multiple specimens were tested. The provenance of this data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory testing conducted by the manufacturer, C.E.I.B.med.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided in the document. The "ground truth" for material performance studies like those described (e.g., flexural strength in MPa, water sorption in μg/mm³) is established through standardized laboratory testing methods and measurements, not through expert consensus on qualitative observations.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., image reading) where multiple experts assess the same case and discrepancies need resolution. For physical and chemical property tests of a dental resin, objective measurements are taken, and adjudication by experts is not a standard practice.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure the impact of AI on reader performance. The Reon device is a dental resin, not an AI software, and therefore such a study is not relevant.
6. Standalone (Algorithm Only) Performance:
No standalone (algorithm-only) performance was done. As Reon is a material (dental resin) and not an algorithm/software, this concept does not apply. The performance evaluated was the physical and chemical properties of the material itself.
7. Type of Ground Truth Used:
The "ground truth" for the performance testing of the Reon dental resin was established through standardized laboratory testing and objective measurements against established material standards (specifically ISO 10477:2020). For example, Flexural Strength is measured by breaking specimens and calculating force per unit area, and Water Sorption is determined by measuring weight changes of specimens after water immersion.
8. Sample Size for the Training Set:
This information is not applicable and not provided in the document. Training sets are relevant for machine learning algorithms. Reon is a physical material, and its development and validation process would involve formulation, experimental testing, and optimization, not a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" for a dental resin product in the AI context. The development of the resin would involve scientific and engineering principles, quality control, and adherence to established material science methodologies.
§ 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.