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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.

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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.

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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.

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