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Gutta percha is inserted into rout canal following root canal preparation.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device named "TGP" (Gutta Percha). It confirms the device's substantial equivalence to legally marketed predicate devices.

This document does not contain any information about:

• Acceptance criteria for a device's performance.
• Any study that proves the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Multi-reader multi-case comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth used.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about a study, as this information is not present in the provided text.

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For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to seal canal walls, to promote healing effects and to help preserve the sealer and sealer / gutta percha interface.

MCS - Martin's Canal Sealer

This is a 510(k) clearance letter for a dental device, not a study report for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth cannot be extracted from this document.

The document discusses the regulatory clearance of "MCS - Martin's Canal Sealer" and states its intended use for sealing root canals. It confirms that the device is substantially equivalent to a legally marketed predicate device, indicating it meets the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

No information regarding AI/ML performance, acceptance criteria, or studies proving such criteria are met is present in this document.

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For use in the final filling of prepared root canals in adult or decidious teeth when antibacterial activity is desired in the final filling agont. Used to promote healing effects and to help provent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases whore antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.

Antibacterial Gutta Percha

This document is an FDA 510(k) clearance letter for an "Antibacterial Gutta Percha" device, K971641. The letter indicates that the device has been found substantially equivalent to predicate devices, thus allowing it to be marketed.

However, the provided text does not contain any information regarding:

• Acceptance criteria or reported device performance.
• Study details (e.g., sample size, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details).

The letter solely focuses on the regulatory aspects of the device's clearance based on its substantial equivalence to previously marketed devices, rather than data from a clinical or performance study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about a study, as this information is not present in the provided document.

Ask a specific question about this device