(54 days)
Porta Solder 1080 W 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 Solder 1080 W is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a white alloy with high contents of precious metals (Gold, Platinum, Iridium and Silver: 88,2%).
Porta Solder 1080 W 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 Euro 50, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.
Porta Solder 1080 W 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 text does not contain information about acceptance criteria or a study proving that Porta Solder 1080 W meets any specific acceptance criteria. This document is a 510(k) premarket notification for a dental brazing alloy, which primarily focuses on establishing substantial equivalence to a predicate device.
Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study as requested. The document does not describe such a study.
§ 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.