Longly Biotechnology (Wuhan) Co., Ltd.

Longly Biotechnology (Wuhan) Co., Ltd. specializes in dental materials used for caries (tooth decay) and plaque detection, such as resin-based caries and plaque indicators. Their portfolio also includes temporary light-cured (LC) resins and filling materials for restorative dental work, as well as bioceramic sealers and repair materials for root canal treatments. These products are designed to assist in diagnostic, restorative, and endodontic procedures.

Longly Biotechnology (Wuhan) Co., Ltd. is based in China. While the company’s location influences its regulatory approach, it does not inherently determine whether its devices are approved or cleared—individual devices must meet the specific requirements of regulatory bodies like the FDA or EU authorities. The company’s devices are listed in the EU’s eudamed registry and the FDA’s 510(k) database, indicating compliance with those jurisdictions’ processes.

Longly Biotechnology’s devices are listed in the EU’s eudamed registry and the FDA’s 510(k) database. These registries serve as official records of device compliance with regulatory standards in those regions. Listing in these databases helps healthcare professionals, distributors, and authorities verify that the devices meet necessary requirements before use, ensuring traceability and accountability in the supply chain.

Longly Biotechnology’s devices are classified as Class I and Class II under regulatory frameworks. Classification determines the level of scrutiny and regulatory oversight required. Class I devices generally pose minimal risk (e.g., some diagnostic tools), while Class II devices carry moderate risk (e.g., certain restorative or endodontic materials) and require additional validation to ensure safety and effectiveness. The classification helps regulators and users understand the device’s risk level and required compliance steps.