Dentalez Alabama, Inc.

Dentalez Alabama, Inc. specializes in dental operating room equipment. Their product line includes line-powered LED dental lights, electric dental chairs, dental suction systems with integrated pumps, gas pipeline and air compressor systems, and dental delivery systems for instruments and materials. These devices are designed to support clinical workflows in dental offices.

Dentalez Alabama, Inc. is based in the United States. Since they operate within the U.S., their devices must comply with applicable U.S. medical device regulations, including registration and reporting requirements. The company’s products are also listed in the FDA’s Unique Device Identifier (UDI) database, which helps ensure traceability and regulatory transparency.

All of Dentalez Alabama, Inc.’s listed devices fall under Class I regulatory classification in the U.S. This classification typically applies to low-risk devices that pose minimal potential harm to patients. Class I devices generally require less stringent regulatory oversight compared to higher-risk categories, though compliance with manufacturing and labeling requirements remains mandatory.

Dentalez Alabama, Inc.’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, transparency, and compliance monitoring. This registry helps healthcare providers, regulators, and other stakeholders verify device details and ensure proper use.