Search Results

The INTERPORE Self-Tapping Threaded Implant is indicated for oral reconstruction in the totally edentulous mandible or maxilla, in large edentulous spans, for bilateral and unilateral free-ends and in restoration of single tooth edentulous spaces. It is designed to become an osteointegrated prosthesis allowing the attachment of removable and fixed partial or complete prosthodontic appliances. The external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications.

The INTERPORE Self-Tapping Threaded Implant is a commercially pure titanium, machined, endosseous threaded implant with an external hex configuration on the top of the implant. The outer surface of the implant is externally threaded. The external threads originate at the inferior edge of the machined coronal collar of the implant and continue to the apical end of the implant. The apical end of the implant contains flutes which act as cutting edges to aid installation of the implant during the self-tapping procedure. The inner diameter of the implant is internally threaded with 2.5 mm threads designed for acceptance of a placement screw, a hex cover screw, a healing abutment, and a retaining screw. The latter device affixes the prosthetic appliance to the implant.

The incorporation of the external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications. It is designed to mechanically interface with a female hexagonal configuration on the mating prosthesis such that, when the retaining screw is tightened into place, the crown will not be allowed to rotate.

The provided text is a 510(k) summary for a dental implant, focusing on device description, indications, materials, and comparison to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way described by your request's numbered points (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance).

The section titled "NONCLINICAL TEST CONCLUSIONS" mentions "Static testing was performed on the INTERPORE Threaded Implant and compared with existing mechanical test data for the Branemark 3.75 mm Threaded Implant. Results showed that the INTERPORE Threaded Implant was significantly stronger than the Branemark implant."

This indicates a mechanical comparison, but not a study designed with the elements you've requested.

Therefore, I cannot populate the table or answer the specific questions about clinical study design, ground truth, or expert involvement as the provided text does not contain that information.

Ask a specific question about this device