(192 days)
The SimpleLine II Abutment System is intended for use as an aid in prosthetic rehabilitation.
SimpleLine II Abutment system is intended for use as an aid in prosthetic rehabilitation. It consists of Cover screw, Healing Abutment, Solid Abutment, Dual Abutment, Abutment Screw, SCA Abutment, Dual Milling Abutment, Angled Abutment (15° and 25°), Direct casting Abutment-Gold, Metal-Casting Abutment-Co-Cr, Temporary Abutment-Ti and Screw Abutment. All of abutment designs are based on existing Implantium that are cleared for marketing in the United States. The materials of the SimpleLine II Abutment System is Ti-6Al-4V ELI alloy(ASTM F136), Pure Titanium Gr4(ASTM F67). Gold alloy, Co-Cr-Mo (ASTM F799), Ti-Gr2(ASTM F67).
The Angled Abutments are available in diameters of 3.8, 4.3, 4.5, 5.5 and 6.5mm with 15° and 25° angles to the axis of the implant.
This document describes regulatory approval for a dental abutment, not an AI/ML powered device. As such, there is no information about acceptance criteria, study details, or ground truth related to AI/ML performance.
The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through material and performance testing, typical for medical device submissions that are not AI/ML driven.
Therefore, the requested information regarding AI/ML device performance, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set specifics cannot be extracted from 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.)