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The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for restorations.

The provided text describes a 510(k) premarket notification for the DIO Implant Systems, a dental implant device. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML medical device.

The "Performance" section (14-8) states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." However, it does not provide details about the specific acceptance criteria, method, sample size, or results of this laboratory testing.

The document primarily focuses on establishing substantial equivalence to a predicate device (SM® IMPLANT SYSTEMS) based on intended use, material, design, and technological characteristics.

Therefore, I cannot fulfill your request for the tables and detailed study information as the provided text lacks the necessary content for acceptance criteria, device performance metrics, study design, sample sizes, ground truth establishment, or expert-related information for an AI/ML device.

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