FOUR D RUBBER COMPANY LIMITED

Four D Rubber Company Limited specializes in Hevea-latex rubber dams. These devices are primarily used in dental settings to isolate the work area during procedures, ensuring moisture control and barrier protection. The company’s portfolio includes products branded under BIODAM and Ultradent, all of which fall under the category of rubber dams.

Four D Rubber Company Limited is based in the United States. While the company’s location doesn’t inherently determine regulatory pathways, it aligns its devices with U.S. requirements, including compliance with FDA regulations. The manufacturer’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting adherence to U.S. medical device reporting standards.

The devices produced by Four D Rubber Company Limited are included in the FDA’s Unique Device Identifier (UDI) database. This registry is a centralised system for tracking medical devices in the U.S., ensuring traceability and compliance with regulatory requirements. Listing in this database is particularly relevant for Class I devices, as it helps streamline post-market surveillance and reporting.

All devices manufactured by Four D Rubber Company Limited fall under Class I classification. This classification is typically assigned to low-risk devices, such as rubber dams, where the risk to patients is minimal and the devices do not require pre-market approval. Class I devices are generally subject to general controls, including good manufacturing practices and registration requirements, but they do not undergo the same rigorous pre-market review as higher-risk categories.