(83 days)
KERADEC is a fuse-on gold paste, which can be used by dental technicians to manufacture dental appliances for patients. It is intended for gold coating of white metal surfaces in cervical areas, elimination of casting cavities, gold coating of occlusal surfaces and inlay imitations. In addition, it can be used within the AGC electroforming technique to manufacture AGC Bridges with the sintering procedure.
KERADEC is a fuse-on gold paste, which can be used by dental technicians to fabricate dental appliances for patients. It consists of spherical gold particles and an organic liquid. KERADEC is intended for gold coating of white dental alloys. It can be used for gold coating of white metal surfaces in cervical areas, elimination of casting cavities, gold coating of occlusal surface and inlay imitations. The use of KERADEC improves the color reproduction of ceramics on white porcelainfused-to-metal alloys. It optimizes the color of white dental alloys and reduces oxidation of these alloys. It does not improve the metal to ceramic bond. For applying, KERADEC has to be brushed onto the surface of the alloy and, after drying, it has to be fired in a ceramic furnace (820°C). In the course of these heat treatments, the organic liquid will completely vaporize and the gold will form a very thin layer of pure gold (99.99%), which is partly diffused into the surface of the alloy. KERADEC is highly corrosion resistant. It meats the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text is related to a 510(k) premarket notification for a dental product called KERADEC. This is a regulatory submission for a medical device and not a study proving device performance against acceptance criteria in the way you've outlined for an AI/algorithm-based device.
The information describes the device, its intended use, and its substantial equivalence to a predicate device. It confirms that the device is a gold-based alloy for clinical use in dentistry, specifically for gold coating white dental alloys and for use in AGC electroforming techniques.
Therefore, I cannot provide the information requested in your numbered list because the provided document does not contain a study or data demonstrating specific performance metrics, test sets, or ground truth establishment for an AI/algorithm.
The document discusses:
- Device Description: KERADEC is a fuse-on gold paste consisting of spherical gold particles and an organic liquid.
- Intended Use: Gold coating of white dental alloys, eliminating casting cavities, gold coating occlusal surfaces, inlay imitations, and use in AGC electroforming.
- Regulatory Classification: Class II medical device (Product Code EJT, Regulation Number 872.3060).
- Predicate Device: Blendgold Special (K 851872).
- Safety/Performance claim: It is highly corrosion resistant and meets the essential requirements of the European directive 93/42/ECC concerning medical devices. However, this is a general statement about compliance, not specific performance metrics from a study.
There is no mention of acceptance criteria, a study proving performance, sample sizes, experts, ground truth, or AI-related metrics in this regulatory filing.
§ 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.