(53 days)
Porta IP Solder V-1 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions.
Porta IP Solder V-1 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with very high contents of precious metals (Gold; Platinum; Iridium and Silver: 99,5%). Porta IP Solder V-1 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions, especially DuoPal 6, Simidur S2 and Simidur KF plus, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta IP Solder V-1 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided document is a 510(k) summary for a dental brazing alloy, Porta IP Solder V-1. It describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.
However, the document does not contain information about:
- Acceptance criteria for a study proving device performance.
- A study demonstrating achievement of acceptance criteria.
- Details regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
Instead, the document focuses on:
- Device Description: Porta IP Solder V-1 is a dental brazing alloy, high in precious metals (Gold, Platinum, Iridium, Silver: 99.5%), intended for joining dental alloy parts to form restorations (e.g., bridges) before firing ceramic dental alloys. It is corrosion resistant and complies with ISO 9333 and European directive 93/42/ECC.
- Predicate Device: Argesol YPF (K942859).
- Regulatory Classification: Class II, Product Code EJT, under 21 CFR 872.3060 (Gold-Based Alloys and Precious Metal Alloys for Clinical Use).
- Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information as it is not present in the given text. The 510(k) summary format for this type of medical device (a material like a solder) typically focuses on material composition, intended use, and equivalence to existing devices rather than a performance study with acceptance criteria in the way a diagnostic or AI-driven device might.
§ 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.