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Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.

Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. They are Zinc Oxide/Eugenol root canal sealants. The products are made up of two separate components, a powder base and a liquid catalyst. to form the final device. The liquid catalyst is the same formulation for both products. Pulp Canal Sealer is a fast setting material, while Pulp Canal Sealer EWT features an extended work time of greater than 6 hours on the pad.

The provided text describes a 510(k) premarket notification for a dental device, "Pulp Canal Sealer and Pulp Canal Sealer EWT." The submission aims to demonstrate substantial equivalence to a predicate device (K945244). The information focuses on non-clinical performance data and does not include details about Artificial Intelligence (AI) or machine learning algorithms. Therefore, many of the requested points related to AI studies (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this document.

However, I can extract information related to the acceptance criteria and non-clinical study for the device's physical and mechanical properties.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the physical and mechanical properties are implicitly derived from the predicate device's performance and the ISO 6876 standard for "Dental Root Canal Sealing materials." The reported device performance is compared against the predicate and against the ISO standard's maximum limits where specified.

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