(49 days)
For preprosthetic build-up in combination with zirconium oxide root canal post
Not Found
I'm sorry, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The text is a 510(k) clearance letter from the FDA for a device called "IPS Empress Cosmo Ingot." This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not contain specific acceptance criteria, performance data, or details of any clinical studies (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details).
The letter primarily focuses on:
- Confirmation of substantial equivalence.
- Regulatory classification and applicable controls.
- General information regarding FDA responsibilities.
- The intended use of the device: "For preprosthetic build-up in combination with zirconium oxide root canal post."
To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a premarket approval (PMA) application summary, which would typically contain the detailed information you are seeking.
§ 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.