Osstem Implant Strengthens Global Clinical Trust with CE MDR Certification
Osstem Implant has obtained CE MDR certification under Regulation (EU) 2017/745 for a portfolio of 4,695 implant and medical device products. The certification confirms that Osstem’s quality management system meets international standards and reinforces trust among European clinicians who prioritize evidence-based practice.
The EU has fundamentally strengthened its regulatory framework by transitioning from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR). Compared to MDD, MDR requires enhanced clinical evidence through continuous Clinical Evaluation, mandates Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF), and integrates risk management and Quality Management Systems (QMS) across the entire product lifecycle. It also increases the rigor and frequency of audits by independent Notified Bodies and improves device traceability and transparency via UDI (Unique Device Identification) and EUDAMED (European Database on Medical Devices). Collectively, this demonstrates that Osstem’s products have officially passed the safety and performance verification required under the strengthened EU regulations.
The certificate was issued by TÜV Rheinland LGA Products GmbH (Notified Body No. 0197). The certificate number is HZ 2292034-1; the EUDAMED single registration number is KR-MF-000020006. Osstem’s EU Authorised Representative is OBELIS S.A., Brussels, Belgium. The scope of certification covers dental devices widely used in clinical practice, including Class I reusable surgical instruments (dental/oral surgery instruments, surgical kits), Class IIa reusable and single-use dental instruments, and Class IIb implantable devices (dental implants and prostheses).
The certified portfolio includes Osstem’s flagship implant systems KS and TS, 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 improve fatigue strength. The TS System delivers strong primary stability and long-term reliability across diverse clinical cases. Surface treatments such as SA, CA, BA, SOI, and RBM enable clinicians to tailor treatment strategies to patient conditions and clinical preference.
Moreover, the key products that have obtained this certification have been significantly improved with the goals of enhancing user convenience, procedural safety, and expanding market competitiveness. The specialized sinus lift kit, New CAS KIT, enhances user convenience by incorporating a Short Drill alongside the standard CAS Kit specifications, and the design of the Membrane lifter was changed to a wing-like structure, offering superior sealing performance that significantly reduces the possibility of membrane perforation. Furthermore, the One485 KIT, a digital surgery dedicated kit for Osstem Implant’s unique Short implant (4-8.5mm) lineup—which allows for implant placement without bone grafting in cases of low residual bone—also received MDR certification, along with the OnePositioning KIT, which determines the precise implant placement and direction, enhancing the accuracy and convenience of digital guide surgery, and the OneGuide KIT(Short), a digital kit for patients with limited vertical space (such as the mandibular posterior region) due to its short-shank drill.
The Link Abutment (2nd Generation) has been greatly diversified, with an Open Type added alongside the existing Closed Type, and four G/H (Gingival Height) options (1mm, 2mm, 3mm, 4mm), 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 the continued use of existing Fixture Level scan bodies simplifies the process and provides cost-saving effects. In addition, the TS Transfer Abutment, with improved screw loosening resistance and strength due to a change in raw material to Titanium, and the GBR Cover Screw, which was redesigned into a dome shape to maintain the GBR space, also completed MDR certification.
This achievement follows MDR certification in August 2024 for 156 products, including surgical kits and digital guided surgery solutions. With the completion of the first and second certification phases, all products manufactured at the Busan Production Center now comply with MDR, further validating Osstem’s manufacturing and quality capabilities. Osstem plans to complete MDR certification for bone grafts, products manufactured outside Busan, and new products by next year, expanding its certification portfolio.
A company spokesperson said, “The CE 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.”
