(272 days)
Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandible or maxilla. Prostheses can be screw or cement retained to the abutment.
Spectra-System Abutments 2008 consist of a number abutment used in conjunction with dental implants for provisional, permanent or laboratory fabrication of a final dental prosthesis. The system includes Non-Engaging Titanium Temporary Abutments, Angled Screw-Receiving Abutments, Narrow ("N" Series) Abutments, Non-Engaging Plastic Abutments, Non-Engaging Gold Abutments and related components.
The provided text is a 510(k) summary for the "Spectra-System Abutments 2008" and a corresponding FDA clearance letter. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with the detailed categories you've provided (e.g., sample size, expert ground truth, MRMC study, etc.).
Therefore, I cannot extract the information you requested because it is not present in the provided document. The document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence based on physical dimensions, material composition, indications for use, and manufacturing methods, rather than clinical performance metrics from a study as described in your prompt.
§ 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.)