(69 days)
The UCC™ Dental Material is used as a bonding agent to facilitate a bond between an opaque resinous veneering material and a gold based metal understructure in the preparation of a Resin-Fused-to-Metal-Restoration (RFM). The UCC™ Dental Material is particularly intended for bonding veneering material 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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental material (UCC™ Dental Material). It confirms substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to the efficacy or performance testing of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text. The document focuses solely on the regulatory approval process based on substantial equivalence, not on a detailed performance study.
§ 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.