Osstem Implant Secures EU MDR Certification: Setting a New Global Dental Standard
Osstem Implant has reached a pivotal milestone by officially obtaining the European Medical Device Regulation (MDR) certification for its extensive product portfolio. This transition from the old directive (MDD) to the rigorous MDR framework is more than just a regulatory update; it is a powerful testament to the company's commitment to clinical safety. By meeting these world-class standards, Osstem Implant strengthens its "Global Clinical Trust," ensuring that practitioners worldwide have access to high-performance, ultra-safe dental solutions.
This certification guarantees that Osstem’s surgical kits and implant systems are backed by high-level clinical evidence, offering peace of mind to both clinicians and patients in an increasingly regulated healthcare landscape.
The Data: Measuring Global Compliance
The scale of this certification reflects Osstem's massive manufacturing and research capabilities:
Certified Volume: A staggering 4,695 products have successfully met the new MDR requirements.
Product Range: Compliance covers Class I reusable instruments, Class IIa dental tools, and Class IIb implantable systems.
Flagship Systems: Core technologies, including the KS and TS implant systems, prosthetic components, and titanium membranes, are now fully MDR-certified.
Production Focus: All products from the Busan production center in South Korea are now produced under these strict guidelines.
Future Roadmap: Osstem aims to complete MDR certification for its bone grafting materials and international manufacturing sites by early 2027.
The Underlying Mechanism: The Shift from MDD to MDR
Why is MDR considered the gold standard for medical safety? The new framework introduces several critical layers of oversight:
Stricter Clinical Evaluation: Manufacturers must provide continuous, real-world clinical data to prove that their devices are safe and effective over long-term use.
Enhanced Traceability: Through the Unique Device Identification (UDI) system, every product is logged into the EUDAMED database, allowing for total transparency across the supply chain.
Proactive Surveillance: Unlike previous rules, MDR requires active post-market monitoring to detect and resolve potential safety issues immediately.
Rigorous Third-Party Audits: Certification requires intense, ongoing inspections from independent bodies like TÜV Rheinland to ensure quality management remains flawless.
Clinical and Professional Implications
For the modern dental clinic, Osstem’s MDR compliance offers several practical advantages:
Unmatched Patient Safety: The certification ensures that instruments, such as the CAS KIT for sinus lifts, have been refined to minimize procedural risks like membrane perforation.
Optimized Digital Workflows: Surgeons can utilize tools like the OneGuide KIT (Short) with confidence, knowing they are engineered for maximum precision in tight surgical spaces.
Technical Upgrades: As part of the MDR review, products like the TS transfer abutment have seen improvements in material strength to prevent common issues like screw loosening.
Regulatory Peace of Mind: Using MDR-certified products protects practices from the legal and clinical risks associated with non-compliant medical devices.
Original Article Details
Original Title: Osstem Implant strengthens global clinical trust with MDR certification
Source: Dental Tribune
Publication Date: January 8, 2026