(129 days)
BruxZir GT (Gum Tissue) Color™ is indicated for metal free single posterior crowns, multiple unit anterior crowns/ bridges including full and partial arches, bonded restorations.
BruxZir GT (Gum Tissue) Color™ is a coloring solution for the gum tissue (gingival) area of full and partial-arch dental restorations. The product can also be used for crowns and bridges when restoration of the gingival area is included. It provides shade consistency, aesthetics and efficiency when preparing a zirconia restoration. The solution is to be applied to green stage restoration before sintering. The BruxZir GT (Gum Tissue) Color™ comes in a 150 mL bottle.
The provided text describes a 510(k) premarket notification for a dental coloring solution, BruxZir GT (Gum Tissue) Color™. The document focuses on establishing substantial equivalence to a predicate device, Zirkonzahn Color Liquid Prettau Aquarell Tissue B (K061851), rather than detailing a specific study to prove the device meets acceptance criteria in the context of diagnostic or screening performance (like an AI/ML device).
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established is not applicable to this document. These details are typically found in submissions for devices that involve diagnostic accuracy or clinical effectiveness studies, which is not the case for this dental coloring solution.
The document primarily focuses on non-clinical performance data to demonstrate substantial equivalence to the predicate device.
Here's the relevant information that can be extracted, framed as acceptance criteria and reported performance where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device/ISO Standards) | Reported Device Performance (BruxZir GT Color™) | Comparison |
|---|---|---|
| Flexural Strength of color treated Zirconia: ≥ 800 MPa | ≥ 800 MPa | Meets |
| Fracture Toughness of color treated Zirconia: ≥ 5.0 MPa · m1/2 | ≥ 5.0 MPa · m1/2 | Meets |
| Solubility of color treated Zirconia: ≤ 100 µg/cm2 | ≤ 100 µg/cm2 | Meets |
| Cytotoxicity: No evidence of cell lysis or toxicity | No evidence of causing cell lysis or toxicity | Meets |
| Sensitization: No reaction | No reaction on the tested subject | Meets |
| Irritation: Non-irritant | Considered a non-irritant | Meets |
| Penetration of coloring solution | Comparability to predicate device demonstrated | Meets |
Note: The "Acceptance Criteria" here are derived from the performance characteristics of the predicate device and relevant ISO standards (ISO 6872:2015, ISO 10993-5:2009, ISO 10993-10:2010), which the subject device aims to meet or exceed to prove substantial equivalence.
2. Sample size used for the test set and the data provenance
Not applicable. This is a non-clinical device comparing physical and biological properties, not a diagnostic device with "test sets" of patient data. The tests were performed on laboratory samples of the material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of expert consensus, is typically for clinical or diagnostic interpretations, which is not relevant for this material.
4. Adjudication method for the test set
Not applicable.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The "ground truth" for the material's properties (flexural strength, fracture toughness, solubility, biocompatibility) is established through standardized laboratory testing methods described by ISO standards (ISO 6872:2015, ISO 10993-5:2009, ISO 10993-10:2010).
8. The sample size for the training set
Not applicable. There is no training set as it is not an AI/ML device.
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.