Search Results

The Xpeed® AnyRidge® Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

The Xpeed® AnyRidge® Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, root-form endosseous dental implant. The Xpeed® AnyRidge® Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type. This system is made from CP Titanium, Gr.4 and Ti-6AI-4V, ELI and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The implantsare used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. This system has 4.0, 4.4, 4.9, 5.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 6.2, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2mm lengths for normal ridge and 6.4, 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures. Fixtures are produced and packaged separately. All included devices in the system are covered by this submission.

The provided text is a 510(k) summary for the Xpeed® AnyRidge® Internal Implant System, which describes a dental implant system. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical efficacy or meeting specific performance acceptance criteria through a study with the new device. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the submission focuses on comparing the new device to existing legally marketed predicate devices to show that it is substantially equivalent. This means it shares similar intended use, technological characteristics (materials, design, sterilization), and manufacturing processes as already approved devices.

Here's a breakdown of why I cannot extract the requested information from the provided text:

• Acceptance Criteria and Reported Device Performance: This document does not establish specific performance acceptance criteria for the Xpeed® AnyRidge® Internal Implant System itself. It primarily compares its design parameters (e.g., diameter, height, material) with those of predicate devices to argue for substantial equivalence.
• Study Proving Acceptance Criteria: A 510(k) submission for this type of device typically relies on non-clinical testing data (e.g., mechanical testing, biocompatibility) and comparison to predicate devices, rather than a clinical study evaluating the new device's performance against specific acceptance criteria. The document explicitly states: "No additional testing was added for this submission," implying that the existing tests for the predicate devices are considered sufficient for demonstrating equivalence.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Training Set Information: Since no dedicated clinical study proving performance against acceptance criteria for this specific device is described, none of this information is available in the provided text.

In summary, the provided document is a regulatory submission for substantial equivalence, not a report on a study demonstrating performance against acceptance criteria for a novel device.

Ask a specific question about this device