(107 days)
The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants.
The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants.
I am sorry, but the provided text is a letter about a 510(k) clearance for a dental abutment and does not contain information about acceptance criteria or a study proving its performance. The document focuses on regulatory approval rather than technical performance data. Therefore, I cannot extract the requested information.
§ 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.