(190 days)
- . Universal and UCLA Abutments are used as patterns for casting of prostheses. The prosthesis (restoration) will be fastened directly to implant by using a screw.
- Impression Posts are used to register the location and position of the implants in mouth.
- Implant Analogs are replicas of the implants and are mounted in stone model.
- . Cement Retained Abutments are used when the abutment is being used as substructure and the crown is attached on it by using dental cement.
- Temporary Abutments are used while the prostheses are being made. This abutment will be used for a short time. A resin material such as Acrylic will be attached to it directly or by cement.
- Tools and Accessories, such as screwdrivers are used to screw in or tighten the screws, coping screw and housing are used to screw retain the coping on the prosthesis. Drill and reamer are used to smooth out the inner surfaces of abutments after casting.
All Universal, UCLA, Cement Retained and Temporary Abutments, Implant Analogs and Impression Posts are compatible and will be used with Branemark Regular Platform (RP) implants from Nobel Biocare, which have 2.70mm external hexagon and 2mm thread. All abutments will be used for fully or partially edentulous and/or for single tooth dental prostheses.
UCLA/Universal Abutments, Impression Posts, Implant Analogs, Cement Retained Abutments, Temporary Abutments, Tools, and Accessories.
This document is an FDA 510(k) clearance letter for dental abutments and related accessories. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical study report or a performance validation report would.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on regulatory clearance, determining substantial equivalence to a predicate device, and outlining the intended uses of the device.
To provide the requested information, a different type of document, such as a "Summary of Safety and Effectiveness" (which often accompanies a 510(k) submission) or a study report, would be needed.
§ 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.