(147 days)
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPD Dental Implant Abutments submission includes the following categories of dental abutment designs: Healing abutments; Temporary abutments; Cementing titanium abutments; Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant. All subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".
I am sorry, but based on the text provided, I cannot fulfill your request. The document describes the FDA's clearance of a dental implant abutment system and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria or results of a study (especially a clinical study with elements like sample size, ground truth, expert adjudication, MRMC studies, or standalone performance) in the context of typical AI/medical device performance evaluation.
The "Performance Data" section mentions bench testing, sterilization validation, cytotoxicity testing, reverse engineering, dimensional analysis, validation of digital workflow, static and dynamic fatigue testing, and a non-clinical worst-case MRI review. While these are performance tests, they are not presented as typical acceptance criteria for an AI/CADe device's diagnostic performance and the study details (sample sizes, ground truth establishment, expert qualifications, etc.) required by your prompt are absent for these tests.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)