(20 days)
This device is a self- tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional application, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge instillations, for full or partial edentulism, an employing minimally invasive surgical intervention.
Representative applications include the following:
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- Temporary (transitional supports for fixed or removable implant-supported prosthesies while conventional implants are integrating.
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- Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes or integrating implants.
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- Introductory system for nervous or apprehensive potential patients, offering a simple methodology for testing out the actual "feel of bone anchored implants, without the major commitment to final restorations; or as an interim system for medical compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication and general well-being, at modest cost levels.
Self-tapping titanium screw, 1.8 mm in width by 13, 15and 18 mm lengths.
This document is a 510(k) premarket notification for the IMTEC Sendax MDI™, a self-tapping titanium screw intended for immediate transitional splinting stability or ongoing fixation of new/existing crown, bridge, and denture installations. The document describes the device, its indications for use, contraindications, complications, and a comparison of its technological characteristics. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide a response that includes the requested information based on the provided text. The document is a regulatory submission for substantial equivalence, not a performance study report.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are presented.
- Sample size used for the test set and the data provenance: No test set or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method for the test set: No test set adjudication is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No MRMC study is mentioned.
- If a standalone performance study was done: No standalone performance study is mentioned.
- The type of ground truth used: No ground truth is described.
- The sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: No training set ground truth establishment is described.
§ 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.