Hager Worldwide, Inc.

Hager Worldwide, Inc. specializes in dental devices, producing both reusable and single-use instruments. Their product line includes reusable items like eye splash shields, dental mirrors, sterilization/disinfection containers, and dental impression trays. They also manufacture single-use periodontal picks and specialized systems such as dental suction systems, irrigation handpieces, and root canal posts. These devices are designed to support various dental procedures, ensuring quality and precision in clinical settings.

Hager Worldwide, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s Class I and Class II categories. This means their products must comply with FDA requirements for safety, performance, and labeling, though individual devices—not the company—are authorized for use. The U.S. headquarters also means their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and verify regulatory compliance.

Hager Worldwide, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized way to identify medical devices, ensuring transparency in tracking and compliance. This registry helps healthcare providers, regulators, and other stakeholders verify the identity of the devices and their regulatory status, though it does not imply company-wide approval—only that individual devices meet FDA requirements for listing.

Hager Worldwide, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls like proper labeling and manufacturing practices. Class II devices involve moderate risk and may require additional controls, such as performance standards or post-market surveillance. The classification determines the regulatory pathway for authorization, ensuring devices meet safety and effectiveness standards before entering the market, but it does not reflect the company’s overall approval status.