POINTIMPLANT Co., Ltd

POINTIMPLANT Co., Ltd specializes in digital dental X-ray imaging devices. These include systems for intraoral and panoramic radiographic imaging, which are designed to provide high-resolution, wireless imaging solutions. The devices are tailored for dental practices to support diagnostic evaluations and treatment planning.

POINTIMPLANT Co., Ltd is based in South Korea. While the company’s headquarters are in Korea, its digital dental X-ray imaging devices are primarily intended for the European market, where they are registered and comply with the Medical Device Regulation (MDR).

POINTIMPLANT Co., Ltd’s digital dental X-ray imaging devices are classified as Class IIb under EU regulations. This classification is determined based on their intended use and associated risks, where Class IIb devices pose moderate to high risks that require stringent regulatory oversight to ensure safety and performance.

Yes, POINTIMPLANT Co., Ltd’s digital dental X-ray imaging devices are registered in the EUDAMED database. EUDAMED is the European Union’s medical device registry, where manufacturers list their devices to ensure transparency and compliance with regulatory requirements across the EU market.