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The HT III SA Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The HT III SA Fixture System is for single and two stage surgical procedures. It is not for immediate load.

1. The HTⅢ SA Fixture System is dental implant made of titanium metal intended to The 111m of I hitalie byelom of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
2. HTⅢ SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has SA surface.
3. The HTII SA Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided text is a 510(k) summary for a dental implant system (HTIII SA Fixture System) seeking substantial equivalence to existing predicate devices. It does not describe any acceptance criteria or a study proving device performance against such criteria in the context of an AI/human comparative effectiveness study or a standalone algorithm performance study.

Instead, this document focuses on demonstrating substantial equivalence through comparisons of:

• Intended Use: The HTIII SA Fixture System is used in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations, and for single and two-stage surgical procedures (not for immediate load). This is directly compared to the predicate HGIII Fixture System, which has identical intended use, and generally aligns with the Straumann Standard Implant.
• Design and Technology: It highlights features like single threads, taper body type, self-tapping, submerged fixture, and internal hex connection, stating it's similar to the predicate HGIII Fixture System.
• Material: The device is made of Pure Titanium Grade 4 (ASTM F67-06), identical to both predicate devices.
• Surface Treatment: While the HTIII SA Fixture uses "SA" surface treatment, the predicate HGIII uses "RBM", and the Straumann Standard Implant uses "SLA". The document states the HTIII SA Fixture's surface treatment is "similar" to the Straumann Standard Implant.
• Biocompatibility and Safety: Biocompatibility tests were conducted according to ISO 10993 standards (ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, and ISO 10993-11), and surface treatment tests were performed. The results were found to be similar to previously cleared predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or AI study details because this document pertains to a medical device (dental implant) and its regulatory clearance process, not an AI or diagnostic imaging device involving performance metrics like sensitivity, specificity, or reader studies.

The "study" referenced in this document is a series of non-clinical tests (biocompatibility and surface treatment) demonstrating the device's safety and performance characteristics are similar to predicate devices, thereby supporting its substantial equivalence for regulatory clearance.

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