(450 days)
For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.
The product is an endosseous dental implant for prosthetic attachment; trade name: Sargon Immediate Load Implant™. It is substantially equivalent to previously marketed models of this device described in premarket notifications K930071 and K961005. In this design, the collar is longer and allows the direct fixation of a prosthesis to the implant with or without the use of an abutment. The material is the same as the predicate devices; i.e., titanium alloy conforming to ASTM standard F136 "Standard Specification for Wrought Titanium 6Al-4V Ell Alloy for surgical Implant Applications."
The provided text describes a 510(k) summary for the Sargon Immediate Load Implant, but it does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The document is a regulatory submission for a dental implant, focusing on its substantial equivalence to previously marketed devices. It details the device's material, indications for use, and confirms FDA clearance. Regulatory letters and forms are included, but there is no technical study data or performance metrics.
Therefore, I cannot provide the requested information based on the given input.
§ 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.