(53 days)
Porta Optimum Solder 710 is intended for use as a solder after 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, compositions and coefficients of thermal expansion.
Porta Optimum Solder 710 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with high contents of precious metals (Gold, Iridium and Silver: 85,5%). Porta Optimum Solder 710 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. lt is intended for use as solder after firing for dental ceramic alloys. The alloys should have appropriate melting ranges, compositions, and coefficients of thermal expansion, especially recommended are Porta Aurium and Porta Maximum, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta Optimum Solder 710 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.
This document is a 510(k) premarket notification for a dental solder, Porta Optimum Solder 710. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is primarily a regulatory submission letter and an "Indications For Use" form.
Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to a predicate device (Argesol 720) based on its composition and intended use, rather than presenting performance study data 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.