History

ODS has been focusing on research and development for several years since its establishment in 2015. As of January 2022, ODS has obtained the medical device certificates for all items that need certification from the Ministry of Food and Drug Safety (KFDA). Some items obtained overseas medical device certificates, especially from FDA or CE, and additional certification works for other items are in progress.

2021

World’s First Clinical Success in Modelless Direct Clear Aligner
Manufacturing Certification for Light-curing Denture Base Resin (KFDA)
Manufacturing Certification for Resin(Clear) for Orthodontic Devices (KFDA)
Manufacturing Certification for Crown Resin(Permanent) (KFDA)
Manufacturing Certification for 3D Optical Impression Acquisition Aid Material (KFDA)
Manufacturing Certification for Temporary Dental C&B Resin (CE)
Manufacturing Certification for ODS Surgical Guide (FDA)
Manufacturing Certification for for ODS Clear resin (FDA Class 1)
Certification for UV Curing Machine (ODS Cure Box) (KC, CE)
Manufacturing Certification for Bruising Prevention Device (KFDA)
Selected as A Business to Support the Acquisition of Overseas Standard Certification

2020

Manufacturing Certification for Orthodontic Material(IBT) (KFDA)
SG Certification (CE)
Surgical Guide Certification (FDA)
Selected as Export Voucher Company
Selected alone as Resin for “K-Dental Project”
Expansion of Corporate Research Institutes

2019

Certification for Medical Devices Manufacturing by KFDA (No. 6509)
Funding Series A from Eastgate Partners
Manufacturing Certification for Temporary Crown resin (KFDA)
Manufacturing Certification for Dental Implant Guide (KFDA)
Manufacturing Certification for Other Prosthetic Materials (KFDA)
Certification for ISO 13485:2016

2018

Acquisition of venture company certificate
Establishment of R&D department
(expanded to corporate R&D center in 2020)

2017

Change of Company Name of “ODS Co., Ltd.”
Acquisition of Excellent Technology Company Certificate

2016

Relocation of Manufacturing Plant
Acquisition of GMP Certificate

2015

Established as ‘One Dental System Co., Ltd.’
Certification for Medical Devices Manufacturing by KFDA (No. 2603)

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