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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.

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