(58 days)
Porta Geo Ti is a gold-platinum alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/ Onlays - Partial crowns - Crowns - Short span bridges . - Long span bridges . - Removable partials . and can be used for - t Telescopic and milling work Porta Geo Ti can be veneered with suitable dental ceramics as well as with dental-composites. In addition Porta Geo Ti in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of Porta Geo Ti are joined to form dental restorations.
Porta Geo Ti is an extra-hard qold-platinum ceramic alloy with high contents of noble metals (95.4%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and removable partials. It is free of copper and therefore suitable for telescopic and milling work as well as for laser welding. For this application it will be delivered in the shape of laser welding wires. Porta Geo Ti 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. Porta Geo Ti can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
The provided text describes a 510(k) premarket notification for a dental alloy named Porta Geo Ti. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Argedent 77PF K 935507) rather than reporting on a study that establishes acceptance criteria through performance data.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC study, standalone performance, ground truth, training set), is not available in the provided text.
The document states that Porta Geo Ti "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 the specific acceptance criteria within these standards, nor does it detail the study (or studies) conducted to "prove" that the device meets them with specific performance metrics. The 510(k) summary is highly focused on a descriptive comparison to the predicate device and asserting compliance with general standards.
§ 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.