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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage procedures, for single- or multiple-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses.

Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installa or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days.

Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

All the subject devices are intended for single use;
The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10 -;
The subject implants are manufactured of Commercially Pure Titanium (Grade 4) and the subject abutments are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136),
The subject implants present a Grand Morse prosthetic interface with internal indexer; cylindrical shape with double threads; cervical diameter equal to the implant body diameter (2.9 mm)
The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for a "Neodent Implant System - GM Narrow Implant System," which is a dental implant system, not an AI/ML device.

The information provided pertains to demonstrating substantial equivalence of a new dental implant system to legally marketed predicate devices, focusing on:

• Indications for Use: Comparing the intended purposes of the new implant system and its components (implants, conventional abutments, temporary abutments, titanium bases) to existing predicate devices.
• Technological Characteristics: Comparing material, design (e.g., interface, shape, threads, gingival height), sterilization methods, and reusability.
• Performance Data: Mentioning biocompatibility testing (ISO 10993 standards), mechanical testing (Dynamic fatigue per ISO 14801), and sterilization validation (ISO 11137 for gamma irradiation, ISO 11135 for Ethylene Oxide).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The text is relevant for a traditional medical device (dental implant system) and its substantial equivalence determination.

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