(52 days)
Simidur KF plus is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Simidur KF plus can be veneered with suitable dental ceramics as well as with dentalcomposites.
Simidur KF plus is a palladium-base ceramic alloy (79,7% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work. Simidur KF plus is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur KF plus can be veneered with suitable dental ceramics and with dental composites.
The provided text describes a Premarket Notification 510(k) for a dental alloy named "Simidur KF plus." This document serves to establish substantial equivalence to a legally marketed predicate device, not to present a study demonstrating the device meets a set of acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document, as it is not a study report.
The document primarily focuses on:
- Device Description: Simidur KF plus is a palladium-base ceramic alloy (79.7% Palladium) for fabricating dental restorations (crowns, bridges, partials, telescopic and milling work).
- Intended Use: To be used by dental technicians to fabricate dental appliances for patients.
- Compliance: States it complies with international standard ISO 9693 and European directive 93/42/ECC concerning medical devices for corrosion resistance and biocompatibility.
- Substantial Equivalence: It is deemed substantially equivalent to the predicate device "Argebond 80" (K 913704).
Therefore, it is impossible to complete the requested table and answer the specific questions about acceptance criteria and a detailed study design from the given text. This document is a regulatory submission for market clearance based on equivalence, not a scientific publication detailing a performance study against specific acceptance criteria.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.