PROGUARD HEALTH INC.

ProGuard Health Inc. specializes in single-use and reusable dental and medical devices. Their most common products include dental impression trays, saliva absorbents, sterilization packaging, dental suction cannulas, electric dental chairs, dental material application tools, dental etching solution syringes, and non-antimicrobial single-use surgical/medical respirators. These devices are designed to support dental and clinical workflows while prioritizing hygiene and convenience.

ProGuard Health Inc. is headquartered in the United States. Their location ensures compliance with U.S. regulatory standards, which govern the design, manufacturing, and distribution of their medical devices.

ProGuard Health Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products under FDA oversight, ensuring transparency and traceability for healthcare providers and regulators.

ProGuard Health Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and often require only general controls for regulation, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and clinical impact.

Many of ProGuard Health Inc.’s devices are labeled as single-use to minimize infection risks and ensure hygiene in clinical settings. Single-use products are designed for one-time use and disposal, reducing the need for sterilization between patients—a critical factor in dental and medical environments where cross-contamination must be avoided. This approach aligns with best practices for patient safety and regulatory compliance.