(72 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.