(80 days)
The Vertex Rapid Simplified is indicated for: 1. Fabrication of full dentures 2. Fabrication of partial dentures
The Vertex hot-curing denture base material is a conventional dough pack heat cured denture base material that consists of polymethyl methacrylate powder with a heat cure monomer consisting of methyl methacrylate. This material complies with the requirements of ISO 1567, Dentistry. Denture base polymers. The pressing technique is the processing method for Vertex hot-curing denture base material. This cadmium-free acrylic has a rapid 20 minutes polymerization cycle (overnight polymerization is also possible). The Vertex hot-curing denture base powder is available in 10 shades.
Here's an analysis of the provided text regarding the Vertex Dental B.V. Vertex hot-curing denture base material, focusing on acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (from predicate devices / ISO standards) | Vertex Rapid Simplified Performance |
|---|---|---|
| Charpy impact strength | ≥ 1.36 kj/m² (from predicate devices) | 11.3 kj/m² |
| Flexural strength | ≥ 78 MPa (from predicate devices) | 85 MPa |
| Flexural modulus | ≥ 2367 MPa (from predicate devices) | 2367 MPa |
| Water absorption | ≤ 22.0 µg/mm³ (from predicate devices) | 22.5 µg/mm³ |
| Water solubility | ≤ 1.5 µg/mm³ (from predicate devices) | 0.11 µg/mm³ |
| Residual monomer |
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.