(52 days)
Simidur S2 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 S2 can be veneered with suitable dental ceramics as well as with dentalcomposites.
Simidur S2 is a palladium-base ceramic alloy with a high content of noble metals (81% ), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from single crowns up to long span bridges with two it has an indication which farges wortials. It is free of silver and suitable for telescopic and milling work. Simidur S2 is highly corrosion resistant and has an excellent biocompatibility. It fully Simidal U2 is highly ochooled ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S2 can be veneered with suitable dental ceramics and with dental composites.
This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. The provided text is a 510(k) summary for a dental alloy, Simidur S2, and the associated FDA clearance letter. It focuses on the device description, its indications for use, and its substantial equivalence to a legally marketed predicate device (Spartan Plus).
Therefore, I cannot populate the requested table or answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria," as this information is not present in the provided text.
§ 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.