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i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications.

• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a ready-to-use premixed bioceramic paste developed for permanent root canal sealer and repair and surgical applications. i-MTA BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. i-MTA BP does not shrink during setting and demonstrates excellent physical properties. i-MTA BP is packaged in a preloaded syringe.

Here's a breakdown of the acceptance criteria and the study details for the Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP), based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore, some of the requested information (like effect size of human readers with vs. without AI, number of experts for ground truth, adjudication methods, details on training set) are not applicable. The information provided relates to a traditional medical device's performance against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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