(246 days)
Indications for use: The PerioSeal® dental implant is intended to be surgically implanted into the edentulous areas of the mandible or maxilla to serve as support for a dental prosthesis. This device is intended for the treatment of edentulism in the totally or partially edentulous population, but limited to those individuals who are suitable candidates for the surgical and prosthetic procedures. The PerioSeal® dental implant is intended for use in the mandible or maxilla as an artificial root structure for replacement of a single tooth or as an abutment for retention of bridgework or dentures of various configurations. This device is intended for sale to or use on the order of a licensed dentist of physician.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental implant called "PerioSeal Dental Implant". It indicates that the device has been found substantially equivalent to predicate devices. However, this letter does not contain any information regarding acceptance criteria, study details, or performance data for the device.
Therefore, I cannot provide the requested information. The document is solely a clearance notification, not a study report or a detailed performance and acceptance criteria document.
§ 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.