(67 days)
The UCP™ Dental Material is used as a bonding agent to facilitate a bond between an opaque porcelain and a gold based metal understructure in the preparation of a Porcelain-Fused-to-Metal-Restoration (PFM). The UCP™ Dental Material is particularly intended for bonding porcelain to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(k) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.
UCP™ Dental Material
This document is a 510(k) clearance letter from the FDA for a dental material. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI/algorithm-based medical device. The document is for a physical dental material (UCP™ Dental Material) used as a bonding agent, not an AI device.
Therefore, I cannot provide the requested information from the provided text.
§ 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.