(27 days)
Portalloy 54 is a gold-palladium 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. Portalloy 54can be veneered with suitable dental ceramics as well as with dentalcomposites.
PORTALLOY 54 is a gold-palladium ceramic alloy with high contents of noble metals (85,3%) 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. It is free of copper and therefore suitable for telescopic and milling work. PORTALLOY 54 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. PORTALLOY 54 can be veneered with suitable dental ceramics and with dental composites.
This document is a 510(k) Premarket Notification for a dental alloy named "Portalloy 54". It describes the device, its intended use, and states that it has been deemed substantially equivalent to a legally marketed predicate device.
Based on the provided text, the document focuses on the regulatory clearance process for a dental material and does not contain information about acceptance criteria or a study proving that a device meets such criteria.
Specifically, the document includes:
- Device Description: Portalloy 54 is a gold-palladium ceramic alloy with high noble metal content (85.3%) for dental restorations like crowns, short/long span bridges, and removable partials. It's also suitable for telescopic and milling work and can be veneered with dental ceramics and composites.
- Regulatory Compliance: It states that the device complies with international standard ISO 9693 and essential requirements of European directive 93/42/ECC. This is a declaration of compliance with standards rather than a report of a specific performance study against acceptance criteria.
- Substantial Equivalence: The FDA's letter states that "the device is substantially equivalent... to legally marketed predicate devices." This is the core of a 510(k) submission, where the new device is shown to be as safe and effective as a previously cleared device, often without new clinical performance data if similarities are strong enough.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The document is a regulatory submission for a dental alloy, not a performance study report for an AI/medical device with specific acceptance metrics.
§ 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.