ASSOCIATED DENTAL PRODUCTS LIMITED

Associated Dental Products Limited specializes in dental cements based on zinc oxide and eugenol. These include powder-liquid formulations like Alganol Powder, Zonalin Complete Quick Set Packs, Eugenol B.P. Liquid, and Zinc Oxide B.P. Powder. These products are primarily used in restorative dentistry and endodontic procedures, such as root canal treatments and cavity fillings.

The company is based in the United States. This location influences its regulatory compliance, particularly under U.S. medical device regulations like the FDA’s Unique Device Identifier (UDI) system.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations, allowing healthcare providers and regulators to identify and track specific products like Alganol Powder or Zonalin Complete.

The devices produced by Associated Dental Products Limited fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks, such as those associated with dental cements in restorative or endodontic applications.