Search Results

Splinting periodontially involved and mobile teeth to prevent movement.

To reinforce full denture and partial denture repairs.

As a matrix between abutinent teeth for receiving a temporary replacement tooth.

As an aid in the reinforcament of temporary crowns and bridgework

As a space maintainer for orthodontically Involved teeth.

Not Found

I am unable to answer this question. The provided document is a 510(k) clearance letter from the FDA for a device called "Splint It™". It states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use.

However, a 510(k) clearance letter does not contain details about acceptance criteria, specific performance studies, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) submission itself, which is a much more extensive document than the clearance letter.

Therefore, based on the provided text, I cannot extract the information required to answer your prompt.

Ask a specific question about this device