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OsseoSpeed™ Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Profile is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

The OsseoSpeed™ Profile is a self-tapping, threaded, root-formed dental implant, intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a microroughened and fluoride-modified surface, designated OsseoSpeed. It includes a contoured coronal margin that mimics the contour of alveolar bone and is designed to create a more desirable esthetic effect.

The provided text is a 510(k) summary for the OsseoSpeed™ Profile dental implant and a subsequent FDA clearance letter. It describes the device's intended use and classification, and states that it is substantially equivalent to predicate devices. However, this document does not contain information about specific acceptance criteria or an analytical study with performance metrics.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training/test set ground truth establishment.

The document primarily focuses on:

• Device Description: Self-tapping, threaded, root-formed dental implant made from titanium with a microroughened and fluoride-modified surface, designed for supporting prosthetic devices. It also notes a contoured coronal margin for esthetic effects.
• Intended Use: To replace missing teeth in single or multiple unit applications, usable in single-stage or two-stage surgical procedures, indicated for immediate implantation in extraction sites or healed alveolar ridges. It can be immediately loaded when primary stability is achieved. It is also indicated for use in soft bone applications.
• Substantial Equivalence: The manufacturer demonstrated the device is substantially equivalent to predicate devices for its indications and design principles.

Missing Information:

The document lacks critical experimental data typically found in a clinical study report or a more detailed 510(k) submission that would include performance testing. To answer your questions, I would need a document that presents:

1. Specific performance metrics and their acceptance thresholds. (e.g., success rate, survival rate, bone loss measurements, ISQ values, etc.)
2. Details of a study conducted to demonstrate these metrics. This would include information on the study design, patient population, data collection, and statistical analysis.

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