Search Results

The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implants OKTAGON® Bone Level Tapered Design are an addition to the currently distributed Dental Implant System® OKTAGON Bone Level. The implants can be used for immediate or early implantation after loss or extraction of natural teeth. The endosteal implant body of the subject device has a conical shape in the coronal region and is cylindrical in the apical region. The apical cylindrical part of the implant is relevant for the given endosteal diameter of 3.3 to 4.1 mm. The implants are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is micro-structured in the endosted part and has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder is polished. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.

This document is a 510(k) Pre-Market Notification for a medical device, specifically Dental Implants OKTAGON® Bone Level Tapered Design. It does not describe an AI medical device or the results of a study proving a device meets acceptance criteria related to AI/software performance.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence to predicate implant devices based on material composition, design, intended use, and mechanical performance (fatigue and breakage tests for physical implants, not AI performance).

Ask a specific question about this device