Company History

SewonMedix Inc. has been accumulated its technology since 2000 and contributed to the development of dental implant industry, and based on the developed technology, SewonMedix Inc. is involved in the industry as a unique member. As a result of efforts in the sole industry field for over 10 years, SewonMedix Inc. became one of the most advanced and acknowledged companies and partners. Dental implant material involves high risk treatment and requires stability and high-quality and many other factors. For the purpose to meet such requirements, SewonMedix Inc. has acquired KGMP, ISO13485, FDA, CE/MDD Certificate and is involved in R&D and treatment research.

• 2019

  Obtained EN ISO 13485:2016

  FDA/UDI system adapted.

  Renewal for KGMP certification.

  Obtained the manufacture permission of MFDS : IH2 SLA Fixture Pre-Mount Type

  2018

  Development for Overdenture system (LT/BT Abutment)

  Lunched the overseas branch in Russia (Moscow)

  Award for outstanding performance of small business.

  2017

  Authorized agreement in Iran market.

  Authorized agreement in Poland market.

  2016

  10. Obtained FDA registration

  06. KGMP re-acquired and level upgraded Certificate for Promising Export Firm by SMB re-acquired

  2006

  01. Sewon Precision Co., Ltd. established

  2009

  12. ISO9001:2008 Quality Management acquired

  2011

  02. Medical device manufacturing permit acquired

  03. KGMP acquired

  2012

  10. Appointed as a cooperation company for Busan Techno Park

  07. Research center established

  11. Incorporated and Business name change :SewonMedix Inc.

  08. Registered as a venture company

  2013

  05. KFDA item permit

  06. KGMP re-acquired and level upgraded

  11.CE/MDDcertification EN ISO13485:2012 certification ISO9001:2008 certification

  03. UNS Registration(688731065)

  2014

  03. Patented : Dental Implant Abutment

  06. Launched IH Implant system

  2015

  12. CE/MDD certification re-acquired