Aibodent Biotechnology Co., Ltd.

Aibodent Biotechnology Co., Ltd. specializes in dental glass ceramics blocks, which fall under the category of dental appliance fabrication materials. These materials are specifically designed as combination materials, meaning they combine properties to enable precise fabrication of dental appliances like crowns, bridges, and inlays. The focus is on restorative and aesthetic dental procedures.

Aibodent Biotechnology Co., Ltd. is based in the United States. Since the company operates within the US market, its devices must comply with FDA regulations. Dental glass ceramics blocks produced by Aibodent are classified as Class II medical devices, which means they undergo premarket notification (510(k)) and are assigned a Unique Device Identifier (UDI) to ensure traceability and regulatory oversight.

Aibodent Biotechnology Co., Ltd.’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identification (UDI) system. These registries ensure that the company’s dental glass ceramics blocks are tracked and comply with US medical device regulations, including classification as Class II devices.

Aibodent Biotechnology Co., Ltd.’s dental glass ceramics blocks are classified as Class II medical devices in the United States. This classification is based on their intended use in dental procedures, where they serve as combination materials for fabricating appliances like crowns and bridges. Class II devices require premarket submission (such as a 510(k)) to demonstrate substantial equivalence to a predicate device, ensuring safety and effectiveness before market authorization.