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Nobel Biocare's TiAdapt™ Abutment System is a set of screw retained preparable abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

The Nobel Biocare TiAdapt™ Abutment System is comprised of preparable titanium abutments which are secured to the Brånemark System® dental implants with a gold abutment screw. This system functions as an anchor to which a single crown can be cemented. When more than one preparable abutment is used, a multi-unit bridge can be cemented to the abutments. The TiAdapt Abutment System also includes a counter torque device and adaptors, temporary cylinders, impression copings and machine Uni-grip screwdrivers.

This document is a 510(k) Pre-market Notification for the Nobel Biocare TiAdapt™ Abutment System. It outlines the safety and effectiveness of the device by comparing it to predicate products. However, it does NOT contain information on acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any specific performance studies with quantitative results.

The document primarily focuses on:

• Device Description: The components of the TiAdapt™ Abutment System.
• Intended Use: Functioning as an anchor for prosthetic devices to restore chewing function.
• Predicate Products: Listing similar Nobel Biocare components already on the market.
• Technological Characteristics: Stating that the characteristics are "identical" to predicate products.
• Summary Of Safety And Effectiveness Concerns: Discussing potential problems encountered with similar abutment systems (e.g., screw fractures, loosening, improper seating). This section lists potential problems as a general safety overview, not as a study proving a specific performance metric was met or evaluating the TiAdapt's performance against these concerns.
• FDA Clearance: The letter from the FDA affirming "substantial equivalence" to legally marketed predicate devices.

Therefore, I cannot provide a table of acceptance criteria or details of a study based on the provided text, as this information is not present in the document. The document describes a regulatory submission for pre-market notification, which establishes substantial equivalence, but not a performance study with specific acceptance criteria and results.

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