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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.

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This looks like a summary of a 510(k) submission for a medical device called "Dentatus MTI™ Anchor Post," which is an endodontic splint.

However, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on:

• Classification and identification of the device.
• A brief literature review asserting the safety and effectiveness of endodontic splints in general, not specifically the Dentatus MTI™ Anchor Post through a dedicated study.
• Substantial equivalence claims to pre-amendment devices and previously cleared devices, which is a regulatory pathway that often bypasses the need for new, extensive clinical studies if a device is sufficiently similar to existing ones.
• Technology details confirming it uses established materials and manufacturing methods.

Therefore, I cannot populate the table or answer your specific questions with the information provided. The document explicitly states: "Endodontic splints made of titanium or titanium alloy have V. been proved safe and effective through the years," implying reliance on general historical use and existing literature rather than a new study for this specific device.

If you have a different document that details acceptance criteria and performance studies for the Dentatus MTI™ Anchor Post, please provide that.

Ask a specific question about this device