Search Results

ScrewIndirect Narrow Dental Implants are implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for immediate loading for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The ScrewIndirect Narrow Dental Implants consist of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of mini-threads near the top of each implant, are manufactured using the same medical grade titanium alloy material and are coated with the same soluble blast media (SBM). The 3.0mmD implants are in addition to previously approved implants in this system, and are the sole subject of this submission.

The provided text describes a 510(k) summary for the "ScrewIndirect Narrow Dental Implants" (K080633). This is a premarket notification for a medical device that demonstrates substantial equivalence to a legally marketed predicate device.

Key takeaway: The submission focuses on adding a new diameter (3.0mm) to an already approved product family. Therefore, no new clinical studies or detailed performance data are presented, as the device is considered substantially equivalent to the predicate device (Implant Direct's Spectra-System K061319).

As such, the information typically requested in your query (acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or available in this type of 510(k) submission. The FDA clearance is based on demonstrating that the new 3.0mm diameter implant has the same physical dimensions, material composition, and manufacturing process as the previously approved implants in the family (K061319).

Therefore, I cannot populate the table or answer the specific numbered questions with data from the provided text.

This 510(k) relies on the existing clearance of the predicate device (K061319) and demonstrates substantial equivalence by showing that the modification (new diameter) does not raise new questions of safety or effectiveness. The FDA's review process for such submissions focuses on comparative analysis with the predicate, rather than requiring new, extensive performance studies like those seen for novel devices or PMAs.

Ask a specific question about this device