(151 days)
PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.
Indications for Use:
- Temporary anterior and posterior crowns;
- Temporary anterior and posterior bridges;
- Removable structures for dentures;
- Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.
The provided text is a 510(k) Summary for a medical device called "PMMA BLOCK." This document describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence, primarily focusing on physical and chemical properties and biocompatibility.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
- A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (ISO Standard) | Requirement for Subject Device (PMMA BLOCK) | Reported Performance (Subject Device) | Reported Performance (Predicate Device K201683) |
|---|---|---|---|
| Flexural Strength | |||
| ISO 10477 | $\geq$ 50 MPa | $\geq$ 50 MPa | $\geq$ 50 MPa |
| ISO 20795-1 | $\geq$ 65 MPa | $\geq$ 65 MPa | $\geq$ 65 MPa |
| Water Absorption | |||
| ISO 10477 | $\leq$ 0.040 mg/mm³ | $\leq$ 0.040 mg/mm³ | $\leq$ 0.040 mg/mm³ |
| ISO 20795-1 | $\leq$ 0.032 mg/mm³ | $\leq$ 0.032 mg/mm³ | $\leq$ 0.032 mg/mm³ |
| Water Solubility | |||
| ISO 10477 | $\leq$ 0.0075 mg/mm³ | $\leq$ 0.0075 mg/mm³ | $\leq$ 0.0075 mg/mm³ |
| ISO 20795-1 | $\leq$ 0.0016 mg/mm³ | $\leq$ 0.0016 mg/mm³ | $\leq$ 0.0016 mg/mm³ |
| Residual Monomer Content | ISO 20795-1: $\leq$ 2.2% | $ |
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.