Search Results

The implant is indicated for use in the mandible and maxilla for use as an artificial root structure for abutments for bridgework and denture retention.

The Steri-Oss implant functions by serving as a replacement for the root portion of natural dentition, upon which a prosthetic may be constructed. Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The implant is threaded with a 3.8 mm width and an 8, 10, 12, 14, 16 and 18 mm length. The superior aspect is flat. Half of the implant is coated with titanium.

The provided text is a 510(k) summary for the Steri-Oss TPS Apical Implant. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information on acceptance criteria for device performance or any studies proving the device meets particular criteria.

Specifically, the "Performance Data" section explicitly states "Not applicable." This indicates that the 510(k) submission relied on substantial equivalence to the predicate device based on technological characteristics rather than requiring new performance studies with specific acceptance criteria.

Therefore, I cannot provide the requested information, as the source document does not contain it.

Ask a specific question about this device