Aidite (Qinhuangdao) Technology Co., Ltd.

Aidite (Qinhuangdao) Technology Co., Ltd. specializes in dental materials and tools used primarily in restorative and prosthetic dental procedures. Their product range includes ceramic materials for dental appliance fabrication, dyes for customizing dental prostheses, custom-made dental anatomy models for treatment planning, temporary crown and bridge resins, and dental composite resins. Additionally, they produce PMMA-based materials, which are commonly used in dental restorations. These devices are designed to support precision and functionality in dental care.

The company is based in the United States. While the name includes 'Qinhuangdao,' which is a city in China, the regulatory and operational presence for their devices is established in the US, where their products are subject to FDA oversight.

Aidite’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This database helps track and identify medical devices regulated by the FDA, ensuring transparency and traceability for healthcare providers and authorities.

Aidite’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and benefits, as outlined in the FDA’s regulatory framework.