(168 days)
The GR Splint Resin System is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment:
The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.
The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.
GR Splint Resin System includes the GR-10 Guide Resin, GR-19 OA Resin, and GR-22 flex Resin. The GR Splint Resin System is made of functional methacrylic resins and inorganic fillers.
The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin It is available in light blue-transparent, clear transparent and rose-transparent shades. The resin is a liquid photo-curable material that is polymerized by image projection systems at 385 nm and 405 nm to create dental appliances. The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin are intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems.
The document describes the GR Splint Resin System, a light-curable resin for fabricating orthodontic and dental objects. It references its substantial equivalence to predicate devices based on performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2. This standard specifies requirements and test methods for denture base polymers. The specific tests performed and their respective acceptance criteria and reported device performance are not explicitly detailed in a comparative table within the provided text. However, the document lists the measured parameters:
| Acceptance Criteria (Governing Standard) | Reported Device Performance (Measurements Performed) |
|---|---|
| ISO 20795-2 (General standard for denture base polymers) | - Flexural Strength |
| - Flexural Modulus / Bending Modulus | |
| - Water Sorption and Solubility | |
| - Fracture Toughness | |
| - Total Work of Fracture Testing | |
| - Tensile Strength | |
| - Elongation at Break | |
| ASTM D256 (Standard test methods for determining the Izod pendulum impact resistance of plastics) | - Not explicitly detailed, but implied by compliance with ASTM D256. |
| ISO 37 (Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties) | - Not explicitly detailed, but implied by compliance with ISO 37. |
| ISO 10993-1 (Biocompatibility testing) | - Biocompatibility |
| ASTM F1980-16 (Standard guide for accelerated aging of sterile medical device packages) | - Shelf-life of 2 years |
The document states, "Performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2 including Flexural Strength, Flexural modulus / Bending module, Water Sorption and Solubility, Fracture toughness, Total Work of Fracture Testing, Tensile Strength, and Elongation at Break." It also notes that the subject and predicate devices "comply with the same performance standards" and undergo the same biocompatibility and shelf-life testing. However, the specific numerical results of these tests for the GR Splint Resin System and the predicate devices are not provided in this excerpt.
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the performance testing or provide details on the data provenance (e.g., country of origin, retrospective or prospective). It only mentions that "Performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2".
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable. The device is a material (resin) and not an AI/diagnostic device that would require expert-established ground truth for a test set. The "testing" refers to physical, mechanical, and chemical properties of the material.
4. Adjudication Method
This information is not applicable as the testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The device is a material, not an AI system or diagnostic tool that would be evaluated in a MRMC study.
6. Standalone (Algorithm Only) Performance
This information is not applicable as the device is a material, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance "study" in this context is established by the specified international and national standards (e.g., ISO 20795-2, ASTM D256, ISO 37, ISO 10993-1, ASTM F1980-16). The material's physical, mechanical, and biocompatibility properties are measured against the requirements set forth in these standards.
8. Sample Size for the Training Set
This information is not applicable. The device is a material, not an AI model that requires a training set. The manufacturing process of the resin would involve formulation and quality control, but not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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