(227 days)
Esthetic Colorant is used for coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations.
Esthetic Colorant, a colorant with a zirconia structure, is a dilute aqueous solution of transition metal salts and lanthanoid metal salts and enables appropriate color adjustment when combined with a pre-sintered zirconia structure such as KATANA Zirconia (K143439).
Esthetic Colorant colors the pre-sintered zirconia structure by applying it with a metal-free brush. The structure is then dried and then sintered at temperatures above 1400°C. Sintering welds the coloring components in Esthetic Colorant, making it possible to adjust the color shade of the zirconia structure.
Esthetic Colorant has 12 shades in bottle size (12 ml). In addition, Esthetic Colorant can only be used by professional technicians in the field of dentistry.
Here's a breakdown of the acceptance criteria and study information for the "Esthetic Colorant" device, based on the provided FDA 510(k) summary:
This document is a 510(k) summary for a medical device that colors pre-sintered zirconia structures for dental restorations. It is not an AI/ML device, and therefore several of the requested sections (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, sample size for training set, ground truth for training set) are not applicable.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (Esthetic Colorant with KATANA Zirconia HT) |
|---|---|
| Flexural Strength: | |
| Equal to or greater than 900 MPa | COMPLIES (for all tested colorants) |
| Coefficient of Thermal Expansion: | |
| Shall not deviate by more than 0.5 x 10^-6 K^-1 from manufacturer's stated value | COMPLIES (for all tested colorants) |
| Chemical Solubility: | |
| Less than to 100 µg/cm² | COMPLIES (for all tested colorants) |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not explicitly stated how many samples were tested for each physical and chemical property, other than that the properties were evaluated according to ISO 6872:2015.
- Data Provenance: Not explicitly stated, but the company is in Japan (Kuraray Noritake Dental Inc.) so it can be inferred that the testing was conducted there. The testing is prospective as it's for a new product submission.
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 material science device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The ground truth refers to adherence to physical and chemical property standards.
4. Adjudication method for the test set
- Not Applicable. See point 3. Testing involves objective measurements against established ISO standards.
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 material science device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a material science device; there is no algorithm or standalone performance in the context of AI.
7. The type of ground truth used
- International Standard Compliance: The ground truth is established by the requirements of the international standard ISO 6872:2015 for dental ceramics. This standard defines the acceptable ranges for physical (flexural strength, coefficient of thermal expansion) and chemical (chemical solubility) properties.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.