(338 days)
The Teeth in an Hour - ARK Implant System is indicated for the treatment of totally edentulous jaws for placement of implant fixtures with immediate load function to restore the patient's chewing function. The following prerequisites must be fulfilled:
- adequate amount of jaw bone
- the quality of jaw bone must be judged as adequate
- capability to open the mouth at least 50mm (this is especially important for lower jaws with the opposite jaw)
The Teeth in and Hour – ARK Implant System is a concept bridging the use of existing modeling techniques through a surgical template that transfers pre-determined implant locations to a patient. Existing modeling techniques are performed to create a model of a patient's jaw in order to pre-determine implant location. A surgical template, comprised of acrylic material with cylinders and sleeves embedded, is produced for the purpose of transfering the pre-determined implant locations to the patient. During surgery, the template is held in position in the patient's mouth using anchor pins, which are based upon the modeling, and osteotomies are created using the surgical template, necessary drills, and accessories. Implants are then placed into the jaw using standard technique, and anchor pins are then removed. After the implants are inserted, this concept then allows for pre-produced prosthetic reconstruction to be attached.
This request cannot be fulfilled by the provided document. The document is a 510(k) summary for a dental implant system. It outlines the device description, indications for use, and regulatory classification. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 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.