(15 days)
Simidur Superior is a palladium - silver 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 Superior can be veneered with suitable dental ceramics as well as with dentalcomposites.
SIMIDUR SUPERIOR is a palladium-silver ceramic alloy with high contents of precious metals (87,0%), intended for dental technicians to fabricate dental restorations.
It has an indication for use which ranges from single crowns up to long span bridges with two or more pontics. In addition, it can be used for removable partials as well as for telescopic and milling work.
SIMIDUR SUPERIOR is highly corrosion resistant and has aan 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 SUPERIOR can be veneered with suitable dental ceramics and with dental composites.
I am unable to extract specific acceptance criteria for the device performance from the provided text. The document is a 510(k) summary for a dental alloy, Simidur Superior, and primarily focuses on its substantial equivalence to a predicate device and its compliance with general regulations and standards.
The text states:
- "SIMIDUR SUPERIOR 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."
However, it does not provide:
- A table of specific acceptance criteria (e.g., minimum tensile strength, maximum corrosion rate, specific biocompatibility test results with acceptance thresholds).
- Any details of a specific study or test results that "prove the device meets the acceptance criteria." The mention of compliance to ISO 9693 implies testing was done, but the results and methodologies are not described in this document.
Therefore, I cannot provide the requested table or details about a study, sample sizes, ground truth, experts, adjudication, or MRMC/standalone studies. This 510(k) summary is a declaration of compliance rather than a detailed report of performance testing.
§ 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.