ABrite Tech (Shanghai) Co., Ltd.

ABrite Tech (Shanghai) Co., Ltd. specializes in water jet flossers, such as the Mysmile device line. These devices use a stream of water to clean between teeth and along the gumline, helping maintain oral hygiene. The company focuses exclusively on this category of dental care products.

ABrite Tech (Shanghai) Co., Ltd. is based in the United States. Since the company operates within the US market, its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes listings for these products, ensuring traceability and compliance tracking.

The devices produced by ABrite Tech (Shanghai) Co., Ltd., such as the Mysmile water jet flossers, are classified as Class I medical devices. This classification is typically assigned to low-risk products where general controls (like good manufacturing practices) are sufficient for ensuring safety and performance. Class I devices often require less stringent premarket review compared to higher-risk categories.

Yes, ABrite Tech’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking and identifying medical devices throughout their lifecycle, ensuring transparency in supply chains, improving patient safety, and facilitating compliance with regulatory requirements. Listing in the UDI database helps healthcare providers and regulators verify product authenticity and recall information efficiently.