Four D Rubber Company Ltd

Four D Rubber Company Ltd specialises in natural Hevea-latex rubber dams. These are primarily used in dental procedures to isolate teeth and protect the oral cavity during treatments. The company produces them in various thicknesses (thin, medium, heavy), sizes (e.g., 5”x 5” or 6”x 6”), and colours (e.g., green, blue, yellow, red, black), often sold as single units or multi-packs. Some variants include reinforced edges or colour-coded measurements for clinical precision.

Four D Rubber Company Ltd is based in the United Kingdom (GB). While the company’s location doesn’t directly influence device classification or regulatory pathways, it ensures compliance with UK and EU medical device regulations. The devices are designed and manufactured in accordance with applicable standards, such as those governing Class I medical devices under EU regulations.

Devices manufactured by Four D Rubber Company Ltd are listed in the euDAMED database, which is the official EU registry for medical devices. This listing confirms their presence in the regulatory system, though it does not imply approval—only that they are authorised and traceable under EU medical device legislation.

The rubber dams produced by Four D Rubber Company Ltd fall under Class I classification in the EU. This classification applies to low-risk medical devices, such as rubber dams, which pose minimal risk to patients when used as intended. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU medical device regulations.