(59 days)
Easy On Universal Glaze & Stain is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.
Doctus Global offers two kinds of Easy On Universal Glaze & Stain:
- V Easy On Universal Stain for artificial teeth
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Easy On Universal Gum Stain for dental prosthesis, artificial gum tissue portion.
- V Easy Liners for Porcelain powder build-up process.
- V Easy Add On for Correcting and Repair process.
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Easy On Crystal Glaze for glazing Lithium disilicate CAD/CAM block crown and bridge
- V Build Up Liquid for porcelain powder build up process
Both systems and other items are a useful finishing system made of paste type Stain & Glaze for dental ceramics.
Fluorescent layering materials for staining and glazing. With Easy On Universal Stain & Gum Stain, you can easily and quickly achieve high quality dental ceramic prosthesis.
Easy On Universal Stain consists of different types of self-glazing colors with various levels of translucency, each Unique replicate natural tooth shade and gum tissue colors and structures, such as incisal translucency, mamelons, detail expressions, halos, and gum tissue.
Over paint Easy On Universal Stains we layer Easy On Universal Structures. With Easy On Universal Structure you can create tooth surface textures found in natural enamel area and gum tissues, in light and thin thicknesses of 0.1 mm - 0.3 mm. With easy applying and high stability. individual surface structures can easily be integrated into the paste with small brush. The low firing temperature does not change the details of the surface, so reliable and aesthetic results are achieved with one or two firings.
The provided document describes a 510(k) premarket notification for a dental device, "Easy On Universal Glaze & Stain." This document is not for an AI/ML medical device, but rather for a traditional medical device (dental materials). Therefore, the questions related to AI/ML specific aspects like ground truth, training sets, MRMC studies, and expert adjudication are not applicable to this submission.
The acceptance criteria and study that proves the device meets the acceptance criteria are based on non-clinical performance testing and biocompatibility testing against established international standards for dental ceramic materials (ISO 6872:2015 and ISO 10993 series).
Here's a breakdown of the requested information based on the provided document, with an emphasis on what is applicable:
1. A table of acceptance criteria and the reported device performance:
The document lists the acceptance criteria for the "Easy On Universal Glaze & Stain" device based on the ISO 6872:2015 standard for "Dentistry - Ceramic materials" and other general performance tests. The test results are stated to have met these requirements.
| ISO 6872 Cl. | Test Item | Acceptance Criteria (Requirements) | Reported Device Performance |
|---|---|---|---|
| 5.1 | Uniformity | The color shall be uniformly dispersed | Meets requirements |
| 5.2 | Extraneous materials | It shall be free from extraneous materials | Meets requirements |
| 5.3 | Mixing and condensation | Shall not form lumps or granules during mixing, and shall neither crack nor crumble during drying. | Meets requirements |
| 7.2 | Radioactivity | Uranium238 shall be less than 1.0 Bq/g | Meets requirements |
| 7.3 | Flexural strength | It shall not be less than 50 MPa | $\ge$ 50 MPa |
| 7.4 | Linear thermal expansion coefficient | It shall be within (12.0 ± 0.5) x 10⁻⁶ K⁻¹ | Meets requirements |
| 7.5 | Glass transition temperature | It shall be within (560 ± 20) °C | Meets requirements |
| 7.6 | Chemical solubility | The mass loss shall be less than 100 µg/cm² | Meets requirements |
Additional Performance Tests:
| Test Item | Acceptance Criteria (Requirements) | Reported Device Performance |
|---|---|---|
| Appearance | When tested by visual inspection, it shall be free from extraneous materials and suitable for use. | Meets requirements |
| Package | When tested by visual inspection, it shall be no damage, extraneous materials and other harmful defects for usage. | Meets requirements |
| Weight | When measured the weight using a balance, the tolerance shall be within ±5%. | Meets requirements |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each performance test. It only states that the tests were performed according to the specified ISO standard.
- Data Provenance: Not explicitly stated regarding country of origin for the test data, but the manufacturer is based in South Korea (Doctus Global). The studies are non-clinical (laboratory-based) and thus the terms retrospective/prospective clinical study do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a non-clinical device. Ground truth, in the context of an AI/ML device, refers to a definitive diagnosis or measurement established by human experts or other means. For this dental material, "ground truth" is established by laboratory measurements conforming to international material standards. No human expert interpretation of images or data for a diagnostic purpose is involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As explained above, this is a non-clinical device. Adjudication methods are relevant for clinical studies involving human interpretation or subjective assessments, typically in AI/ML performance evaluations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a non-clinical device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems in comparison to human readers, which is not relevant for a dental glaze and stain product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this non-clinical device, "ground truth" is established by objective, quantitative measurements obtained through standardized laboratory testing methods (e.g., flexural strength, chemical solubility, physical properties) as defined by ISO 6872:2015. Biocompatibility "ground truth" is established through tests based on ISO 10993 series.
8. The sample size for the training set:
- Not Applicable. This is a non-clinical device; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for this conventional medical device.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.