Search Results

Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Implants are intended for single use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the (MDI ORTHO) Endosseous Implant. It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain the kind of detailed information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

This letter is a regulatory clearance document, not a scientific study report. It states that the device is substantially equivalent to a predicate, which means the FDA believes it is as safe and effective as a device already on the market. The specific studies and data supporting that determination are typically submitted in the full 510(k) submission, which is not provided here.

Therefore, I cannot populate the requested information from the given text.

Ask a specific question about this device

This device is a self-tapping titanium threaded screw indicated for long-term intra-bony applications, or as an inter-radicular transitional application.

This device will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial endentulism, and employment of minimally invasive surgical interventions.

Representative applications include the following:

• Temporary (transitional supports for fixed or removable implant-supported prosthesis while O conventional implants are integrating.)
• Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to O avoid iatrogenic damage to healing grafts, membranes or integrating implants.
• Introductory system for nervous or apprehensive potential patients, offering a simple O methodology for testing the actual "feel" of bone anchored implants, without a major commitment to final restorations.
• As an interim system for medically compromised, handicapped or terminally ill patients to O enhance their comfort by maintaining a reasonable level of speech, mastication and general well being, at modest cost levels.

This device is a self-tapping titanium threaded screw indicated for long-term intra-bony applications, or as an inter-radicular transitional application.

This device will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial endentulism, and employment of minimally invasive surgical interventions.

Representative applications include the following:

• Temporary (transitional supports for fixed or removable implant-supported prosthesis while O conventional implants are integrating.)
• Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to O avoid iatrogenic damage to healing grafts, membranes or integrating implants.
• Introductory system for nervous or apprehensive potential patients, offering a simple O methodology for testing the actual "feel" of bone anchored implants, without a major commitment to final restorations.
• As an interim system for medically compromised, handicapped or terminally ill patients to O enhance their comfort by maintaining a reasonable level of speech, mastication and general well being, at modest cost levels.

This document is a 510(k) clearance letter from the FDA for a dental implant, the IMTEC Sendax MDI ORTHO. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device