(55 days)
Porta Implant is a gold-palladium-platinum 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 Porta Implant can be veneered with suitable dental ceramics as well as with dentalcomposites.
PORTA IMPLANT is a gold-palladium-platinum ceramic alloy with high contents of noble metals (97,6%) 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. At porcelain fusing temperatures, it has a high sagresistance and therefore it is suitable for manufacturing of implant supraconstructions. PORTA IMPLANT 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 IMPLANT can be veneered with suitable dental ceramics and with dental composites.
The provided document, K030312 for Porta Implant, describes a dental alloy and does not contain information related to software or AI-driven medical devices that would typically have acceptance criteria, performance studies, sample sizes for test/training sets, expert adjudication, or MRMC studies.
Therefore, I cannot extract the requested information from this document. It appears to be a traditional medical device submission for a material rather than a diagnostic or analytical tool involving complex algorithms or human interpretation of outputs.
§ 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.