(97 days)
- 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.
| Acceptance Criteria (from ISO 6876) | Reported Device Performance (Vista BC Putty) | Comparison to Predicate/Reference Devices |
|---|---|---|
| Set Time | ≤ 90 minutes | Shorter than predicate ( |
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.