(36 days)
Imagine h.e. is a dental porcelain that is used by dental technicians to fabricate infagine mor 10 a metal or to press-ceramic restorations. It is suitable for veneering alloys with a high coefficient of thermal expansion [CTE(25 - 500°C): 16.1-16.7 x 10°K']], alleyo www ed restorations, and heat-pressed ceramic frameworks made of the Imagine h.e. Press-Ceramic.
Imagine h.e. can be used for veneering of inlays, partial crowns, crowns, and bridges.
Imagine h.e. is a dental porcelain. It provides an easy to use and aesthetically pleasing dental restorative material to fabricate dental restorations. With its naturescent, brilliant shade effect, Imagine h.e. offers the dental technicians optimum conditions for achieving an exact reproduction of natural teeth.
Imagine h.e. is a dental glass-ceramic containing of leucite crystals (
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a dental porcelain product (Imagine h.e.), detailing its description, classification, and indications for use, along with official correspondence from the FDA confirming substantial equivalence to a predicate device. It does not include performance data or studies against specific acceptance criteria as would be typical for a device with measurable performance metrics.
Therefore, I cannot provide the requested information in the table or address the subsequent points about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
§ 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.