(543 days)
SD Abutment is intended for use in partially or fully edentulous maxilla, in support of single or multipleunit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.
SD Abutment made of Ti-6A1-4V ELI alloy (ASTM F136) and/or Pure Titanium Gr4 (ASTM F67) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Solid Abutment, Dual Abutment, Dual Long Abutment, Angled Abutment (15° and 25°), Temporary Abutment and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.
This document, a 510(k) summary for the SD Abutment, details its substantial equivalence to previously marketed devices. It does not contain information about a study proving the device meets acceptance criteria derived from a performance study involving AI and human readers, nor does it provide a specific table of acceptance criteria with reported device performance.
The document primarily focuses on demonstrating that the SD Abutment is substantially equivalent to predicate devices based on design, materials, and intended use, rather than presenting a novel performance study against specific acceptance criteria. This is typical for a 510(k) submission for dental implant abutments, where the primary regulatory pathway is demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information from the provided text, as the document details a 510(k) submission for a dental implant abutment, not a performance study of a medical device involving AI, human readers, or specific performance metrics like those found in clinical studies for diagnostic or assistive AI tools.
§ 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.)