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The MIS Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The MIS Dental Implant System consists of one and two stage implants, internal and external hexagonal; cover screw and healing caps; abutment systems and suprastructures; surgical instruments.

The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document describes a 510(k) summary for the "MIS Dental Implant System," which is a premarket notification to the FDA to demonstrate substantial equivalence to existing legally marketed devices.

The information primarily focuses on:

• Device Description: Components of the MIS Dental Implant System (implants, cover screws, healing caps, abutments, surgical instruments).
• Materials: Implants are made from medical grade 4 (GD-4) pure titanium (ASTM F67-95).
• Intended Use: Surgical and restorative applications in the upper or lower jaw to support prosthetic devices and restore chewing function.
• Predicate Devices: Comparison to 3i Dental Implant System and ITI Dental Implant System.
• Substantial Equivalence Claim: The device has the same intended use and equivalent performance characteristics to the predicate devices.
• FDA Clearance Letter: Confirmation of substantial equivalence by the FDA.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided text. The document is a regulatory submission, not a scientific study report.

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