(90 days)
To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodentic appliance in the mandible or maxilla.
ENDURE endosseous implant
This document is a 510(k) clearance letter for the ENDURE Endosseous Implant. It confirms that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it typically include detailed information about clinical trials, performance metrics, ground truth, or expert qualifications in the way you've requested.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than extensive clinical studies with specified acceptance criteria as one might see for novel, high-risk devices or software as a medical device (SaMD).
Therefore, based solely on the provided text, I cannot fill in the requested table and information. Most of the points you've asked for are related to clinical studies and performance evaluation that are not typically included in a 510(k) clearance letter itself.
To answer your questions, one would need to access the full 510(k) submission (if publicly available or by contacting the manufacturer), which would contain the detailed test reports and justification for substantial equivalence.
§ 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.