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DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.

DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.

Implants are intended for immediate loading on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (Ø6.0 mm and above) implants.

Specific indications for small diameter (Ø3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

DEFCON TSA / TSH dental implant systems are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are composed of Titanium commercially pure, feature different implant to abutment connection options and are available with modified surfaces to promote improved osseointegration. Implant abutments are composed of Titanium commercially pure, Titanium alloy 6Al 4V and POM-C.

Primary stability, adequate osseointegration and mechanical performance of the implant connection are fundamental to implant success. Device design characteristics including the thread profile, geometry, surface finish and crestal characteristics are based on these concepts.

The provided text describes the "IMPLADENT DEFCON TSA/TSH Dental Implant Systems," a root-form endosseous dental implant. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and a study to prove performance against those criteria in the way a clinical trial might.

Therefore, the information requested regarding acceptance criteria, device performance, study characteristics (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set details for an AI/CAD device is not available in the provided text.

The document explicitly states:

• "No clinical studies are submitted." (Section 5: 510(k) SUMMARY)
• The device was subject to "bench testing to determine conformance to performance [requirements]... specifically including mechanical performance... and biological testing in accordance with the level and duration of contact with the human body, surface finish evaluation including chemical analyses, and sterilization process validation." (Section 5: 510(k) SUMMARY - NON-CLINICAL TEST SUMMARY)

This indicates that compliance was demonstrated through non-clinical, laboratory bench testing, not through human clinical studies where acceptance criteria for diagnostic accuracy (common in AI/CAD systems) would typically be evaluated.

The "acceptance criteria" in this context are related to the mechanical, biological, and material properties of the implant, which were likely evaluated against industry standards or internal specifications during bench testing. However, the specific metrics and comparison to reported performance are not detailed in the summary provided.

In summary, as this is a 510(k) for a physical medical device (dental implant) and not an AI/CAD system, the requested information on acceptance criteria, clinical study design, and performance metrics (like sensitivity, specificity, reader improvement, etc.) is not applicable or present in the provided document.

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