Soluria II LLC

Soluria II LLC specializes in denture cleansers, which are designed to clean and maintain dental prosthetics. These devices are intended for use in oral hygiene routines to help remove plaque and bacteria from dentures, ensuring better oral health for users.

Soluria II LLC is based in the United States, meaning its devices fall under the jurisdiction of the FDA. Since the company’s products are classified as Class I medical devices, they are subject to FDA regulations, including requirements for listing in the FDA’s Unique Device Identification (UDI) system.

Soluria II LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators.

Soluria II LLC’s denture cleansers are classified as Class I medical devices by the FDA. This classification is typically assigned to devices that pose minimal risk to users, such as low-risk cleaning products, and generally requires less stringent regulatory oversight compared to higher-risk devices.