SEOUL, South Korea: Osstem Implant has obtained certification under Regulation (EU) 2017/745 (Medical Device Regulation) for a portfolio of 4,695 implant and medical device products. The certification confirms that Osstem’s quality management system meets international standards and supports confidence among European clinicians in the reliability and regulatory oversight of the certified products. The scope of certification covers dental devices widely used in clinical practice, including Class I reusable surgical instruments and kits, Class IIa reusable and single-use dental instruments, and Class IIb implantable devices.
The EU has fundamentally strengthened its regulatory framework by transitioning to the Medical Device Regulation (MDR). MDR requires enhanced clinical evidence through continuous clinical evaluation, mandates post-market surveillance and post-market clinical follow-up, and integrates risk management and quality management systems across the entire product life cycle. It also increases the rigour and frequency of audits by independent notified bodies and improves device traceability and transparency via unique device identification and the European Database on Medical Devices (EUDAMED). Collectively, the MDR certification process demonstrates that Osstem’s products meet the safety and performance requirements of the strengthened EU regulations.
The certified portfolio includes Osstem’s KS and TS flagship implant systems, as well as prosthetic components, orthodontic screws and titanium membranes. The KS system adopts a single platform to enhance workflow convenience in surgical and prosthetic procedures and to improve fatigue strength. The TS system delivers strong primary stability and long-term reliability across diverse clinical cases. The availability of multiple Osstem implant surface treatments—such as SA (sand-blasted and acid-etched), CA (calcium-treated), BA (bioabsorbable apatite), SOI (Super OsseoIntegration) and RBM (roughened by resorbable blasting media)—enables clinicians to tailor treatment strategies to their clinical preferences and the patient.
Key products that have obtained MDR certification have been significantly improved with the goals of enhancing user convenience and procedural safety and expanding market competitiveness. The specialised sinus lift kit, the CAS KIT, enhances user convenience by incorporating a short drill alongside the standard CAS KIT specifications, and the design of the membrane lifter has been changed to a wing-like structure, offering superior sealing performance that significantly reduces the possibility of membrane perforation.
Furthermore, the One485 KIT, OnePositioning KIT and OneGuide KIT (Short) received MDR certification. The One485 KIT is a guided surgery kit dedicated to Osstem’s unique short implant line-up (4.0–8.5 mm), which allows for implant placement without bone grafting in cases of limited residual bone. The OnePositioning KIT determines the precise implant placement and direction, enhancing the accuracy and convenience of guided surgery. The OneGuide KIT(Short) is a guided surgery kit for patients with limited vertical space, such as in the mandibular posterior region, and incorporates short drills to accommodate reduced clearance.
The portfolio of link abutments has been greatly diversified. An open type has been added alongside the existing closed type, as well as four gingival height options (1, 2, 3 and 4 mm), resulting in a total of 48 specifications. The addition of the open type, in particular, enables aesthetic procedures in highly visible areas, such as the maxillary anterior region, while compatibility with existing implant-level scan bodies streamlines the workflow and reduces additional component costs.
In addition, the TS transfer abutment and GBR cover screw obtained MDR certification. Owing to a change in raw material to titanium, the TS transfer abutment now has improved screw loosening resistance and screw strength, and the GBR cover screw was redesigned into a dome shape to maintain the guided bone regeneration space.
This new achievement for Osstem follows MDR certification in August 2024 for 156 products, including surgical kits and guided surgery solutions. The first and second certification phases having been completed, all products manufactured at Osstem’s production centre in Busan in South Korea now comply with MDR, further validating the company’s manufacturing and quality assurance capabilities. Osstem plans to complete MDR certification for its bone grafting materials, products manufactured outside Busan and new products by next year.
A company spokesperson said, “The MDR certification demonstrates that our quality and clinical standards meet the strengthened EU regulations. We will continue to collaborate with European clinicians to deliver MDR‑compliant, reliable solutions that improve patient outcomes and enhance global trust in our brand.”
The certificate was issued by TÜV Rheinland LGA Products (notified body No. 0197). The certificate number is HZ 2292034-1, and the EUDAMED single registration number is KR-MF-000020006. Osstem’s EU authorised representative is Obelis in Brussels in Belgium.
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