(123 days)
"Glaze Paste, Glaze Powder, and Glaze Liquid" are indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
"Glaze Paste, Glaze Powder, and Glaze Liquid" is a dental veneering material used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make the artificial teeth (dental prosthesis) more similar with natural teeth.
"Glaze Paste, Glaze Powder, and Glaze Liquid" are actually three products: Powder, paste, and liquid. "Glaze Powder" is in the form of a porcelain dry powder and liquid. When mixed together by the technician at a dental lab, they form the paste stain before applied to the patient.
"Glaze Paste" is pre-mixed paste from porcelain powder and liquid, which can help dental technicians save the mixing process.
The porcelain powder is composed primarily of SiO2, with minor components of Al2O3, K20, Na2O, Li2O, and color additives. The liquid is composed of deionized water and organic solvents. The liquid can also be used as a thinner to control viscosity of paste.
"Glaze Paste, Glaze Powder, and Glaze Liquid" are supplied in seventy one different colors, with or without fluorescence effect.
The provided text describes a 510(k) submission for a dental product (Glaze Paste, Glaze Powder, and Glaze Liquid), focusing on demonstrating substantial equivalence to a predicate device, not on proving that an AI/device meets specific clinical performance acceptance criteria. Therefore, most of the requested information regarding AI device acceptance criteria, study details, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.
However, I can extract the general acceptance criteria and performance data for the material itself, based on the regulatory standards mentioned.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states that "Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the 'Glaze Paste, Glaze Powder, and Glaze Liquid' met its specifications. All tests were verified to meet acceptance criteria." It also mentions "Biocompatibility testing was performed to verify the equivalence of the materials that are used."
The specific numerical acceptance criteria from ISO 6872:2015 are not explicitly listed in the document. However, the document does state that the device "conforms to ISO 6872, Dentistry, Ceramic Materials" and "test results met all relevant requirements in the test standard."
For biocompatibility, the document explicitly lists that the subject device's performance met the criteria of ISO 10993.
| Test Category | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Material Performance | Conformance to ISO 6872:2015 requirements for dental ceramic materials (e.g., radioactivity, transition temperature, thermal expansion, flexural strength) | "All tests were verified to meet acceptance criteria." "Results met all relevant requirements in the test standard." "Results are very similar to the predicate device." |
| Cytotoxicity | No cytotoxicity effect (per ISO 10993-5:2009) | "No cytotoxicity effect" |
| Irritation Oral Mucosa | Not a primary oral mucosa irritant (per ISO 10993-10: 2010) | "Not a primary oral mucosa irritant under the conditions of the study" |
| Sensitization | Not a sensitizer (per ISO 10993-10: 2010) | "Not a sensitizer under the conditions of the study" |
| Acute Toxicity | No acute toxic effects observed (per ISO 10993-11: 2006) | "No acute toxic effects observed" |
| Subacute & Subchronic Toxicity | No subacute and subchronic toxic effects observed (per ISO 10993-11: 2006) | "No subacute and subchronic toxic effects observed" |
| Genotoxicity | No genotoxic effects observed (per ISO 10993-3: 2003) | "No genotoxic effects observed" |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "bench testing" and "biocompatibility testing" but does not specify sample sizes for these tests, nor the data provenance beyond "internal procedures."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a material testing conformity rather than an AI or diagnostic device that requires expert ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this pertained to material performance and biocompatibility testing, not an AI or diagnostic study requiring human adjudication of results.
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 not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For material performance, the "ground truth" would be the chemical and physical properties as defined by the international standard ISO 6872:2015. For biocompatibility, the in vitro and in vivo test results against the criteria of ISO 10993 standards serve as the "ground truth."
8. The sample size for the training set
Not applicable. This is a material, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.