FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The M root-form endosseous dental implant fixture is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore the patient's chewing function. The M endosseous dental implant abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The M root-form endosseous dental implant is not intended for immediate loading.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a dental implant, which primarily states that the device is substantially equivalent to a legally marketed predicate device. It does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

Ask a Question

Ask a specific question about this device

K Number

K072447

Device Name

PENTABORN

Manufacturer

MEDISCITEC INC.

Date Cleared

2008-02-15

(168 days)

Product Code