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Data / Medical devices / South Korea / DIO Corporation

DIO Corporation: FDA-registered device maker in Haeundae-gu Busan, South Korea, 25 510(k) clearances

DIO Corporation is registered with the FDA (registration 3007126709) in Haeundae-gu Busan, South Korea. It lists 18 device types. The FDA files 25 510(k) clearances under its listings, the newest dated August 18, 2023. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch DIO Corporation
FDA registration number
3007126709
Address
66, Centumseo-ro, Haeundae-gu Busan, South Korea, 48058
Owner or operator
DIO Corporation (9089142)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
September 7, 2006
Registered through
2027
Brand names listed
1.2 Hex Driver, Bar holder Abutment, Bar holder Cap Abutment, Beak Action Chisel, Bone Condenser, Bone File, Connector Extension, Cortical Drill and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Manufactureraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Manufactureraccessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture ToothPZY2Manufactureraccessdata.fda.gov
Attachment, Precision, AllEGG1Repackager or relabeleraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Manufactureraccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Exporter to the USaccessdata.fda.gov
Drill, Dental, IntraoralDZA1Manufactureraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Exporter to the USaccessdata.fda.gov
Handpiece, Water-PoweredEKY1Exporter to the USaccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Exporter to the USaccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Exporter to the US, Manufactureraccessdata.fda.gov
Teeth, Artificial, Posterior With Metal InsertELJ1Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 18, 2023K220253Eco Abutment, Multiunit AbutmentNHASubstantially EquivalentDio Corporationaccessdata.fda.gov
March 23, 2021K210828DIOnavi-Denture02EBISubstantially EquivalentDio Corporationaccessdata.fda.gov
October 22, 2020K193623DIOnavi-DentureEBISubstantially EquivalentDio Corporationaccessdata.fda.gov
May 18, 2020K193404UF(II) Bar holder abutmentNHASubstantially EquivalentDio Corporationaccessdata.fda.gov
February 21, 2020K192263UCLA CCM AbutmentNHASubstantially EquivalentDio Corporationaccessdata.fda.gov
September 30, 2019K190048UF(II) Anatomic abutmentNHASubstantially EquivalentDio Corporationaccessdata.fda.gov
December 21, 2018K181037DIO CAD/CAM AbutmentNHASubstantially EquivalentDio Corporationaccessdata.fda.gov
December 14, 2018K182194UV Active Implant SystemDZESubstantially EquivalentDio Corporationaccessdata.fda.gov
June 1, 2018K173975UF(II) Wide FixtureDZESubstantially EquivalentDio Corporationaccessdata.fda.gov
March 30, 2018K170608UF(II) Implant SystemDZESubstantially EquivalentDio Corporationaccessdata.fda.gov
February 21, 2017K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - SuprastructureDZESubstantially EquivalentDio Corporationaccessdata.fda.gov
February 19, 2015K142358Osstell IDxEKXSubstantially EquivalentOsstell ABaccessdata.fda.gov
October 31, 2014K141570IMPLANT STUDIOLLZSubstantially Equivalent3Shape Medical A/Saccessdata.fda.gov
May 21, 2013K122519DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEMDZESubstantially EquivalentDio Corporationaccessdata.fda.gov
December 18, 2012K123695TRAUS SIP10EKYSubstantially EquivalentSaeshin Precision Co., Ltd.accessdata.fda.gov
November 10, 2010K100100DIO STEADY EXTERNAL IMPLANT SYSTEMDZESubstantially EquivalentDio Corporationaccessdata.fda.gov
September 21, 2009K092758X-CUBEEBWSubstantially EquivalentSaeshin Precision Co., Ltd.accessdata.fda.gov
October 9, 2008K080559DIO SM IMPLANT SYSTEMDZESubstantially EquivalentDsi, Inc.accessdata.fda.gov
May 30, 2008K080129SECURE IMPLANT SYSTEM (2.5/3.0MM)DZESubstantially EquivalentDio Department Dsi, Inc.accessdata.fda.gov
May 16, 2008K073070DIO BIOTITE-H IMPLANT SYSTEMDZESubstantially EquivalentDio Department Dsi, Inc.accessdata.fda.gov
May 14, 2008K080128SM-EXTRA WIDE (RBM) IMPLANT SYSTEMDZESubstantially EquivalentDio Department Dsi, Inc.accessdata.fda.gov
April 15, 2008K070570DIO IMPLANT SYSTEMDZESubstantially EquivalentDio Department Dsi, Inc.accessdata.fda.gov
April 11, 2008K080126DIO PROTEM IMPLANT SYSTEMDZESubstantially EquivalentDio Department Dsi, Inc.accessdata.fda.gov
November 8, 2007K070569SM INTERNAL./EXTERNAL IMPLANT SYSTEMDZESubstantially EquivalentDio Department Dsi, Inc.accessdata.fda.gov
September 1, 2006K061797SM IMPLANT SYSTEMSDZESubstantially EquivalentDio Department Dsi, Inc.accessdata.fda.gov

Compare with other makers

Updated August 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.