PRISMAN INC.

Prisman Inc. specializes in dental and medical cleaning products, including professional dental abrasive materials like polishing pastes and powders, dental articulation pastes, and ultrasonic-cleaning solutions. Their portfolio also covers dental-specific items such as etching solutions (delivered via single-use syringes), denture cleansers, and cleaning agents for medical devices. Additionally, they produce water bath systems for ultrasonic cleaning and injection cannulas for dental materials, all designed for precision and efficiency in clinical settings.

Prisman Inc. is based in the United States, which means its devices must comply with U.S. regulatory standards. Since all listed devices fall under Class I classification—typically the lowest risk category—they are subject to general controls under the FDA, including registration, listing, and UDI requirements. The company’s U.S. location ensures alignment with domestic regulatory frameworks, such as FDA’s Unique Device Identifier (UDI) database, where its products are registered.

Prisman Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, a centralized registry that tracks medical devices authorized for commercial distribution in the U.S. The UDI system ensures transparency in device identification, traceability, and compliance with FDA requirements. This database is critical for healthcare providers, regulators, and distributors to verify product details and regulatory status.

All of Prisman Inc.’s listed devices are classified as Class I under U.S. FDA regulations. This classification applies to low-risk products, such as dental abrasives, cleaning agents, and syringes, which generally pose minimal risk to patients and users. Class I devices are subject to general controls (e.g., manufacturing practices, labeling, and UDI requirements) but do not require pre-market approval or rigorous clinical trials, as they are deemed safe and effective through established standards and experience.