(59 days)
UltraThineer Zirconia Slurry is indicated for use by dental technicians in the construction of custommade ceramic restorations. These include copings, crowns, inlays and onlays, veneers, and bridges (3-unit anterior bridges).
The UltraThineer Zirconia Slurry is a ceramic slurry intended for use in fabricating custom-made ceramic restorations using 3D printing and sintering processes. There is a single formulation: Zirconia-5Y/BMF-5YZ-1.6B. The UltraThineer Zirconia Slurry is provided as a slurry contained in a sealed tamper-proof and opaque HDPE bottle, with product labeling. The bottle containing the slurry has dimensions of 3.5" in diameter and 7.75" in height and has a maximum volume of 0.75L. For use, the slurry is poured into a vat inside the 3D printer for printing the dental veneer. After printing, the veneer is sintered to yield the final product. Each veneer will be custom fabricated on a named patient prescription basis on the order of a dentist.
The provided text describes a 510(k) premarket notification for a medical device called "UltraThineer Zirconia Slurry (5Y-B)". This document primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study proving the device meets specific acceptance criteria in the manner of a clinical trial for an AI/software device.
Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance are not applicable to this type of regulatory submission because it is for a material (zirconia slurry) and not an AI/software device.
However, I can extract the relevant "acceptance criteria" (performance parameters) and "reported device performance" from the Non-Clinical Performance Data (Bench Testing) and Biocompatibility Testing sections as the "study" that proves the device meets these criteria.
Here's the breakdown of the information that can be extracted, and where the information is absent or not relevant for this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (UltraThineer Zirconia Slurry) |
|---|---|
| Biocompatibility (ISO 10993-1) | Met biocompatibility requirements (Chemical Characterization, Cytotoxicity, Sensitization, Oral Mucosal Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity) |
| Radioactivity (ISO 6872:2015) | Activity concentration of uranium238 less than 1.0 Bqg-1 (meeting ISO 6872 requirements) |
| Flexural Strength (ISO 6872:2015) | >300 Mpa (meeting ISO 6872 requirements) |
| Linear Thermal Expansion Coefficient (ISO 6872:2015) | Mean linear thermal expansion coefficient within 0.5 x 10^-6 K^-1 of the value reported by the manufacturer (meeting ISO 6872 requirements) |
| Chemical Solubility (ISO 6872:2015) |
§ 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.