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The ITI synOcta angled abutments for Wide Neck Implants are indicated for use in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are angled abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The angled abutment is used for angulation correction in cases where the position of the dental implant requires an angled reconstruction for an optimal restoration.

The 15° synOcta angled abutment for the Wide Neck Implant is made from commercially pure Grade 4 titanium (F67). The basal portion of the abutment has an 8° conical taper with an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the basal portion of the abutment. The abutment is used for cemented restorations.

This document is a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information, which typically comes from performance studies.

Here's why the document doesn't contain the requested information:

• Substantial Equivalence: The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is often done by comparing design, material, intended use, and performance characteristics, rather than conducting new clinical trials or extensive performance studies with predefined acceptance criteria.
• Focus on Design and Material: The document explicitly states that "The ITI synOcta angled abutments for the Wide Neck Implant are substantially equivalent in intended use, material, and design to the ITI synOcta angled abutments cleared under K994119." This indicates that the equivalence is based on these aspects, not necessarily on new performance data against specific acceptance criteria.
• No Performance Study Description: There is no section describing a study conducted to test the device's performance against specific metrics. The document details the device's description and intended use but not any testing methodology, results, or acceptance thresholds.

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