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UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

UCLA CCM Abutment is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constrainsts. After customization, be sure to use only dental non-precious metal for casting to make the prosthesis. When cast a prosthesis with UCLA CCM Abutment, the post height above the transmucosal collar of UCLA CCM Abutment has to be taller than 4mm. The subject device is not to be used with any angulation and are straight only. UCLA CCM Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. Both abutments types are compatible implant bodies (K182194, K161987, K122519, K170608 and K173975). UCLA CCM Abutments are made from CCM Alloy. UCLA CCM Abutment consists of UCLA CCM Abutment and abutment screw. It is provided non-sterile, this should be user steam sterilized before use.

This document is a 510(k) Premarket Notification for a dental device, specifically an endosseous dental implant abutment. It does not pertain to an AI/ML medical device, and therefore does not contain the information required to answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML.

The document discusses:

• Device Name: UCLA CCM Abutment
• Regulation Number: 21 CFR 872.3630 (Endosseous Dental Implant Abutment)
• Regulatory Class: Class II
• Indications for Use: Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Predicate Devices: NP-Cast Abutment System (K121843), UV Active Implant System, CCM Cylinder (K182194), DIO CAD/CAM Abutment (K181037), and various UF implant systems.
• Non-clinical Testing: Refers to in-vitro testing for fatigue (though none was done as the design does not include angulation), sterilization validation, and biocompatibility, leveraging data from predicate devices.
• Clinical Testing: Explicitly states, "No clinical testing was performed for this submission."

Therefore, I cannot provide details on acceptance criteria and study data related to an AI/ML device's performance, as outlined in your request, because this document describes a physical medical device (dental abutment) and not an AI/ML algorithm.

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