(81 days)
The FRIALIT-2 ® Bone Profiler in intended to be used for the removal of bone that has grown over the top of the implant during the integration period.
The FRIALIT-2 Bone Profiler is part of the FRIALIT-2 Dental Implant System. The Bone Profiler consists of a stainless steel drill guide. The drill is available in the same diameters as the FRIALIT-2 implant bodies. The Bone Profiler is designed to remove bone that has grown over the top of an implant during the integration period. The FRIALIT-2 Bone Profiler can be used in a standard latch handpiece or by hand in a lab handle.
This document is a 510(k) summary for the FRIALIT-2 Bone Profiler, an accessory to a dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in the provided text. The document describes a medical device (a bone profiler used in dental implant procedures) and its substantial equivalence to an existing device, which is a different type of regulatory submission than one requiring a detailed performance study like those for AI or diagnostic tools.
The document primarily provides:
- Device Description: The FRIALIT-2 Bone Profiler is a stainless steel drill guide designed to remove bone overgrowth from dental implants.
- Intended Use: Used in the FRIALIT-2 Dental Implant System for single tooth restorations, edentulous spans, free-standing bridges, and retaining overdentures, for immediate, delayed immediate, or late implant placement.
- Predicate Device: Implant Innovations Inc., Bone Profiler (K960417).
- Substantial Equivalence Claim: The FRIALIT-2 Bone Profiler is similar to the predicate device in design, material, function, and intended use.
- Regulatory Classification: Class III, product code DZE.
- FDA Clearance: Cleared by the FDA on January 10, 22000, based on substantial equivalence.
In summary, none of the requested information about acceptance criteria or a performance study is present because this document is a 510(k) summary for a medical device claiming substantial equivalence, not a performance study for an AI or diagnostic device.
§ 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.