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For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for the apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. These indications include application in: Intracanal Medicament, Apexification, Periapical Lesions, Root Resorption, Temporary Root Filling, Perforations, Underdeveloped pulpless teeth.

DIAPEX is a yellow radiopaque calcium hydroxide paste with iodoform, used as a root canal filling material. It is packaged as a 2 gm syringe. Intraoral application uses enclosed disposable intracanal tips.

This document is a 510(k) summary for the medical device "DIAPEX," a calcium/iodoform root canal treatment paste. The purpose of this summary is to demonstrate that DIAPEX is substantially equivalent to a legally marketed predicate device, Vitapex Pre-loaded dental syringe (K973667).

The document does not contain information regarding a study with specific acceptance criteria and detailed device performance metrics in the format requested. Instead, it relies on demonstrating substantial equivalence to a predicate device through a comparison of intended use, chemical composition, and mechanical/physical properties.

Therefore, many of the requested sections below cannot be populated from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The submission focuses on substantial equivalence rather than performance against pre-defined acceptance criteria from a specific study. The "reported device performance" is implied to be equivalent to the predicate device's performance.

2. Sample size used for the test set and the data provenance

Not applicable. No specific test set or study with performance data is presented. The substantial equivalence argument relies on direct comparison of characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a test set is not established as no performance study is described.

4. Adjudication method for the test set

Not applicable. No test set adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a treatment paste, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a treatment paste, not an algorithm.

7. The type of ground truth used

Not applicable. No performance study requiring a specific type of ground truth is described. The "ground truth" for substantial equivalence is the characteristics and intended use of the predicate device.

8. The sample size for the training set

Not applicable. No training set is relevant for a medical paste device submission based on substantial equivalence.

9. How the ground truth for the training set was established

Not applicable. No training set is relevant for a medical paste device submission.

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