(120 days)
The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.
The Zimmer® Patient-Specific Abutment is a titanium alloy abutment for use with endosseous dental implants to provide support for prosthetic devices. The abutment is manufactured using individual patient-specific requirements to create a design that facilitates functional, as well as, esthetic restoration. Ensure the implant size and abutment angulation are appropriate for the occlusal load. Highly angulated abutments should be avoided in the posterior region.
This document is a 510(k) summary for the Zimmer® Patient-Specific Abutment, Internal Hex, Titanium. It describes a medical device and its intended use, but it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The document is a pre-market notification (510k) submission to the FDA. Its primary purpose is to demonstrate substantial equivalence to a predicate device, not to present performance data against specific acceptance criteria for a new, innovative device that would typically involve AI or complex software.
Therefore, I cannot provide the requested information in the format specified because the input text does not contain it. This type of regulatory submission focuses on material equivalence and general design features, along with mechanical testing to confirm equivalence (as mentioned in point 6: "In addition, the new device is substantially equivalent to the predicate as evidenced in mechanical testing."), rather than a detailed performance study with acceptance criteria as would be expected for a novel AI 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.