(191 days)
This device is designed to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.
The Intra-Lock International Transitional Implant System consists of root form Transitional Implants and restorative components which can be used for cement retained or and removable overdenture type restorative options. The implants are 1.8mm in width by 10, 15 and 8mm in length. The implants are sterile packaged and include a placement instrument.
The provided 510(k) summary for the Intra-Lock Transitional Implant System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is a "Special 510(k): Abbreviated 510(k)" which typically relies on demonstrating conformity with recognized standards or guidance documents rather than presenting new clinical study data with specific acceptance criteria. The submission states it provides information to "demonstrate conformity with FDA's guidance document entitled Endosseous Implants 872-3640."
Therefore, I cannot populate the requested tables and answer the questions based on the provided text. The document concludes that the device is "safe and effective for its intended use" based on "indications for use, technological characteristics, and comparison to predicate devices," but it does not detail specific performance metrics, acceptance criteria, or a study that directly measures performance against those criteria.
§ 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.