(78 days)
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.
§ 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.