Search Results

The Hero I Dental Implant 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 Hero I Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.

The Hero I Dental Implant System is made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition an performance characteristics. The surface of the system has been treated with R.B.M (Resorbable Blast Media).

This submission (K121098) is for the Hero I Dental Implant System. It's a 510(k) summary, which means the manufacturer is asserting substantial equivalence to previously cleared devices, not necessarily demonstrating "meets acceptance criteria" through a comprehensive study with specific performance metrics.

The provided document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance or ground truth establishment for a study related to acceptance criteria.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.

The document primarily focuses on establishing substantial equivalence based on similarities in intended use, technology, materials, and design to predicate devices. It states that "no new question of safety or effectiveness has been raised" when compared to the predicate devices.

Therefore, I cannot fulfill your request for this input, as the information required is not present in the provided text.

This 510(k) summary is analogous to an application stating "my new car is substantially equivalent to existing cars because it has four wheels, an engine, and seats, and therefore meets the same basic safety standards." It doesn't include details of crash test performance (acceptance criteria and reported performance) that would typically be found in a study demonstrating such.

Ask a specific question about this device