Search Results

RealSeal XT Sealer is indicated for permanent root canal obturation and sealing, in combination with root canal points or an obturator.

RealSeal XT Sealer is intended for permanent obturation of root canals of teeth in combination with root canal points. The subject device is a self-etch methacrylate/epoxy resin root canal sealant in a catalyst/base paste formulation, which combines the methacrylate and epoxies resin chemistry. Due to its self-etching and adhering properties, RealSeal XT Sealer does not require the use of an etchant, primer or adhesive to achieve its intended function. It has also been designed for dual cure capabilities. That is, it not only self-cures after mixing the catalyst and base parts in a specific time period, but it can also be light cured by the doctor if there is a need to see an immediate hardening of the material, which facilitates the immediate cleaning of the material after a root canal filling procedure. RedSeal XT Sealer will be packaged in a 4 ml dual-barrel syringe for both the catalyst and base parts. The material can be mixed using an auto-mixing tip attached to the syringe or the material can be mixed by hand on a paper pad, if desirable.

I'm sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a root canal sealant (RealSeal XT Sealer) and focuses on demonstrating substantial equivalence to predicate devices, rather than outlining specific acceptance criteria or detailed study results.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Reported Performance: The document mentions "bench testing used to evaluate the performance characteristics of RealSeal XT Sealer compared to the predicate devices. The characteristics evaluated include working time, water solubility and bond strength." However, it does not provide a table of specific acceptance criteria (e.g., "working time must be between X and Y minutes") nor the reported device performance values against those criteria. It only states that the performance is "substantially equivalent" to predicate devices based on these tests.
• Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Details, Training Set Details: These are all aspects related to a clinical study or a more detailed performance evaluation, typically seen with AI/ML devices or more complex diagnostic tools. The provided text describes a dental material and its bench testing for physical properties, not a clinical study involving human subjects or AI algorithms that would require such details.

The document is a submission for a medical device that demonstrates equivalence through biocompatibility and comparative bench testing of physical properties, not a study evaluating human reading performance or AI algorithm accuracy.

Ask a specific question about this device