(15 days)
Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.
The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.
The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.
The SIMPACT Endosseous Dental Implant System, Line Extension
This document is a 510(k) summary for the SIMPACT Implant System, which is a dental implant device. It is a submission to the FDA requesting clearance to market the device.
As such, this document describes the device and asserts its substantial equivalence to a predicate device based on similar indications for use, materials, design, and principles of operation. It does not contain information about acceptance criteria, clinical studies, sample sizes, expert qualifications, or ground truth establishment in the context of device performance evaluation.
Therefore, I cannot provide the requested information from this document. It does not contain the details of a study that proves the device meets specific acceptance criteria as it would for a medical AI/software device.
§ 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.)