ChangZhou BoMedent Medical Technology Co., Ltd.

ChangZhou BoMedent Medical Technology Co., Ltd. specializes in dental devices primarily used in endodontic procedures. Their portfolio includes ultrasonic endo activation devices (like the Actor I pro), apex locators (such as BOMEDENT and WISMY models) for measuring root canal length, dental electrical motors for rotary instrumentation, root canal measuring and treatment units, and obturation devices to seal treated canals. These tools are designed to assist in precise and efficient root canal therapy.

The company is headquartered in Changzhou, China. This location reflects its focus on manufacturing and supplying dental devices tailored for global markets, including those regulated by the European Union and the United States.

The company’s devices are registered in the EU’s eudamed database, which is the official portal for medical device information under EU regulations. Additionally, some of their products are listed under the FDA’s 510(k) premarket notification process, indicating compliance with U.S. regulatory requirements for Class II devices. These listings demonstrate their adherence to both European and American regulatory frameworks.

The company’s devices fall under EU Class II and Class IIa classifications, which typically apply to devices posing moderate risks (e.g., those requiring special controls to ensure safety and performance). Some of their products are also categorized as Unclassified (U) in certain regulatory frameworks, meaning they may not require formal classification but still adhere to general safety and performance standards. Classification depends on factors like intended use, risk level, and procedural complexity.