(70 days)
The Brånemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Brånemark System implant products that are the subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, either machined or modified (TiUnite) surface, and are already commercially available.
The provided text describes a 510(k) summary for various Brånemark System Dental Implant Products, specifically regarding an expanded indication for immediate function. It does not contain information about acceptance criteria or a study proving that a device meets those criteria, as typically seen in submissions for AI/ML-enabled devices.
The submission is for a medical device (dental implants) where the technological characteristics are stated to remain "substantially unchanged" and "no design modifications were made that effect safety and effectiveness." The "Performance Data" section merely states: "Clinical results show that the expanded Indications for Use are as safe and effective as the original Indications for Use." This is a general statement and does not provide specific acceptance criteria or detailed study results.
Therefore, for your request, I must report that the provided text does not contain the requested information regarding acceptance criteria and a study proving a device meets those criteria.
The document is a 510(k) summary focusing on the equivalence of an expanded indication for use for dental implants, not a detailed performance study for a new or modified device with specific acceptance metrics. The questions you've asked are typically relevant for AI/ML-driven devices or those with quantifiable performance metrics that need to be demonstrated against pre-defined acceptance criteria. This document doesn't fall into that category.
§ 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.