ETGAR - MEDICAL INSTRUMENTS LTD

ETGAR - Medical Instruments Ltd specializes in dental implants and associated components. Their portfolio includes two-piece screw endosteal dental implants, permanent and temporary preformed suprastructures (like abutments), single-use dental impression trays, and reusable surgical tools such as screwdrivers, torque wrenches, and depth/angle gauges. These devices support dental procedures like implant placement and restoration.

ETGAR - Medical Instruments Ltd is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products are listed in the FDA’s 510(k) and UDI registries, they comply with U.S. requirements for medical device authorization, ensuring traceability and post-market monitoring.

ETGAR’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that new devices are substantially equivalent to existing ones, while UDI registration ensures standardized identification for tracking and compliance. This helps healthcare providers and regulators verify device safety and performance.

ETGAR’s devices fall into Class I and Class II FDA classifications. Class I devices generally pose minimal risk (e.g., single-use dental impression trays), while Class II devices require special controls to ensure safety and effectiveness (e.g., dental implants and surgical tools). The classification determines the regulatory scrutiny and documentation required for authorization.

ETGAR produces both reusable tools (like surgical screwdrivers, torque wrenches, and sterilization containers) and single-use components (such as dental impression trays and temporary abutments). Reusable tools undergo rigorous cleaning and sterilization protocols to maintain safety across multiple procedures, while single-use items are designed for one-time application to minimize infection risks and ensure consistency.