(105 days)
The HDC Sterile Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.
The HDC Sterile Spider Screw is a titanium fixation device to be inserted into the upper or lower jaws. designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only. The Sterile Spider Screw is provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screw is manufactured from ASTM F67 and ASTM F136. Self Drilling and Self Tapping Spider Screw is manufactured from ASTM F136. HDC Sterile Spider Screw is provided in three tip size diameters: 1.3 mm, 1.5 mm and 2.0 mm.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (HDC Sterile Spider Screw) to establish substantial equivalence to predicate devices, rather than a performance study report.
Therefore, I cannot provide the requested table or details about a study.
§ 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.