(44 days)
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.
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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.
§ 872.3890 Endodontic stabilizing splint.
(a)
Identification. An endodontic stabilizing splint is a device made of a material, such as titanium, intended to be inserted through the root canal into the upper or lower jaw bone to stabilize a tooth.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.