(79 days)
AGC Speziallegierung is a gold-platinum ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/Onlays, Crowns, Short span bridges, Long span bridges, Pontics for AGC bridges, Removable partials and can be used for Telescopic and milling work. AGC Speziallegierung can be veneered with suitable dental ceramics as well as with dental-composites.
AGC Speziallegierung is a gold-platinum ceramic alloy with a high content of noble metals (97,5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and single crowns up to long span bridges with two or more pontics and pontics for AGC bridges. In addition, it can be used for manufacturing removable partials. It is free of copper and suitable for telescopic and milling work. AGC Speziallegierung 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. AGC Speziallegierung can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
The provided text describes a dental alloy (AGC Speziallegierung) submission for 510(k) premarket notification to the FDA. The information focuses on the device description, its intended use, and its substantial equivalence to a predicate device. It does not contain any information regarding acceptance criteria, a study proving the device meets acceptance criteria, or any details about AI/algorithm performance.
Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, expert opinions, or AI performance, as this information is not present in the provided text.
The document primarily states:
- Device Name: AGC® Speziallegierung
- Device Type: Gold-platinum ceramic alloy for dental restorations.
- Intended Use: Fabrication of inlays/onlays, single crowns, short span bridges, long span bridges, pontics for AGC bridges, removable partials, and for telescopic and milling work. It can be veneered with dental ceramics and composites.
- Compliance: Complies with international standard ISO 9693 and European directive 93/42/ECC.
- Substantial Equivalence: Deemed substantially equivalent to the legally marketed device BioPorta G (K012826).
To fulfill your request, specific performance data, acceptance criteria, and study details would need to be provided.
§ 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.