Search Results

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

Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.

The provided text describes the regulatory clearance of a dental root canal filling material, Vista BC Putty. It references non-clinical performance testing but does not include information about clinical studies, expert-based ground truth, or MRMC studies that are typically associated with AI/ML-based medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ISO 6876 standards for dental root canal sealing materials. The reported performance indicates compliance with these standards and comparability to predicate devices.

Ask a specific question about this device