(70 days)
Porta Geo Ti is a gold-platinum ceramic 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 Telescopic and milling work. Porta Geo Ti can be veneered with suitable dental ceramics as well as with dentalcomposites.
Porta Geo Ti is an extra-hard gold-platinum ceramic alloy with a high content of noble metals (95,4%), intended for dental technicians to fabricate dental restorations. lt 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. 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". It focuses on the device description, its intended use, and its equivalence to a predicate device. However, it does not contain any information about a study proving device performance against acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions from the provided text. The document refers to compliance with ISO 9693 and the European directive 93/42/ECC, which implies that certain performance criteria are met, but it does not detail a specific study or present performance data.
Here's what I can extract from the provided text about the device:
Device Description and Claims (Not Acceptance Criteria or Performance Data):
- Device Name: Porta Geo Ti
- Device Type: Extra-hard gold-platinum ceramic alloy
- Intended Use: For dental technicians to fabricate dental restorations.
- Indications: Inlays/Onlays, Crowns, Short span bridges, Long span bridges, Removable partials, Telescopic and milling work.
- Composition: High content of noble metals (95.4%), free of copper.
- Properties Claimed: Highly corrosion resistant, excellent biocompatibility.
- Compliance: Fully complies with international standard ISO 9693 and fulfills essential requirements of European directive 93/42/ECC.
- Aesthetic Benefit: Golden yellow color provides an excellent basis for aesthetically pleasing dental restorations when veneered with suitable dental ceramics or composites.
Missing Information:
The provided text does not include:
- A table of acceptance criteria.
- Reported device performance data.
- Details of any study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Argedent 77PF, K935507) based on device characteristics, indications for use, and compliance with general standards, rather than presenting a detailed 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.