(114 days)
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:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- 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).
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.