Search Results

Porta Optimum Solder 900 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, compositions and coefficients of thermal expansion.

Porta Optimum Solder 900 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: 93,8%). Porta Optimum Solder 900 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 dental ceramic alloys with appropriate melting ranges, compositions, and coefficients of thermal expansion, especially Porta Aurium, Porta Maximum, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta Optimum Solder 900 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.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert involvement, adjudication methods, or study designs (MRMC or standalone) related to the "Porta Optimum Solder 900" or its "Argesol #760" predicate.

The document is a 510(k) premarket notification summary and an FDA clearance letter for a dental brazing alloy. It describes the device, its intended use, and states that it complies with international standards (ISO 9333) and European directives (93/42/ECC) regarding corrosion resistance and essential requirements for medical devices. However, it does not provide the specific study details you are asking for.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them with the requested details.

Ask a specific question about this device