Osstem Implant’s K1 Factory Receives KGMP Recertification, Reinforcing Global Quality Standards

Busan, South Korea – Osstem Implant, a leading global dental implant manufacturer, announced that its core production facility, the K1 plant (Orange Tower) in Busan, has been recertified as compliant with the Korea Excellent Manufacturing Practice (KGMP) standards for medical devices by the Ministry of Food and Drug Safety (MFDS). This recertification underscores Osstem Implant’s commitment to maintaining the highest standards of quality and safety in its manufacturing processes.

Simplified Inspection Process Highlights Facility Excellence

The K1 factory underwent a simplified KGMP inspection process, a recognition of its status as an excellent medical device manufacturing facility. Located in the Seokdae Advanced Industrial Complex in Haeundae-gu, Busan, the K1 plant holds historical significance as the site of Korea’s first implant development, and production. It currently operates as the world’s largest implant production base by single factory standards.

K1 Plant: A Global Production Hub

Spanning a total floor area of 19,108㎡ (approximately 5,790 pyeong), the K1 plant boasts an annual production capacity of 18 million implant sets. Since its relocation and completion in 2014, it has served as a crucial production hub, supplying implants to dental professionals both domestically and internationally. The facility’s large-scale production capacity and rigorous quality control systems have earned it a strong reputation within the dental community.

Stringent Quality Control Measures

Osstem Implant implements a comprehensive quality control system throughout the entire manufacturing process, from raw material receipt to finished product shipment. This includes ‘6 Critical Process Controls’ and a ‘5-Step Precision Inspection System,’ targeting a defect rate of less than 100PPM (Parts Per Million – less than 1 defect per 10,000 units). The company continually invests in advanced manufacturing environments, including clean rooms, DI Water facilities, and robotic processes, to further enhance quality.

Global Quality Certifications

The K1 factory’s commitment to quality is further demonstrated by its attainment of quality certifications from major countries, including Korea’s KGMP, the U.S. FDA, Europe’s MDR, Japan’s QMS, and China’s CFDA Osstem Implant.

Expansion of Production Capacity

Osstem Implant is actively expanding its production capacity. The K2 factory, which began full-scale operation in 2023, has an annual production capacity of 12 million sets and is scheduled for a regular KGMP inspection in April. The company operates additional production bases in Sihwa (K3), Gyeonggi Province, Philadelphia (A1) in the U.S., and Yancheng (C1) in China PRNewswire.

“We are continuously upgrading our quality management system to maintain a high level,” stated an Osstem Implant official. “We will acquire certification and manage quality with public trust both internally and externally.”