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Data / Medical devices / South Korea / Diadent Group International

Diadent Group International: FDA-registered device maker in CHONGJU CITY Chungbuk, South Korea, 20 510(k) clearances

Diadent Group International is registered with the FDA (registration 9616128) in CHONGJU CITY Chungbuk, South Korea. It lists 23 device types. The FDA files 20 510(k) clearances under its listings, the newest dated September 16, 2026. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Diadent Group International
FDA registration number
9616128
FEI number
3010138769
Address
16, Osongsaengmyeong 4-Ro, Osong-Eup HEUNGDUKGU, CHONGJU CITY Chungbuk, South Korea, 28161
Owner or operator
DiaDent Group International (9033762)
Roles
Exporter to the US, Foreign private label distributor, Manufacturer
First device listed
May 5, 1998
Registered through
2026
Brand names listed
ABSORBENT PAPER POINTS(STERII.E PAPER POINTS), Barbed Broaches, Brush Handle, Brush Tips, D-Lux+, DIA-CEM, DIA-ENDORING, DIA-GP GAUGE and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Manufactureraccessdata.fda.gov
Applicator, ResinKXR1Manufactureraccessdata.fda.gov
Broach, EndodonticEKW1Manufactureraccessdata.fda.gov
Cement, DentalEMA2Manufactureraccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufactureraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Manufactureraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Foreign private label distributor, Manufactureraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Manufactureraccessdata.fda.gov
Gutta-PerchaEKM1Manufactureraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Exporter to the USaccessdata.fda.gov
Material, ImpressionELW2Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Foreign private label distributoraccessdata.fda.gov
Pick, MassagingJET1Manufactureraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Manufactureraccessdata.fda.gov
Point, Paper, EndodonticEKN1Manufactureraccessdata.fda.gov
Preparer, Root Canal EndodonticEKQ1Manufactureraccessdata.fda.gov
Resin, Root Canal FillingKIF2Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.fda.gov
Tip, Rubber, Oral HygieneJEW1Foreign private label distributoraccessdata.fda.gov
Zinc Oxide EugenolEMB1Manufactureraccessdata.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
September 16, 2026K254152Dia-X Sil Light BodyELWSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
September 16, 2026K254142Dia-X Sil Heavy BodyELWSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
July 9, 2026K261166DIA-CEMEMASubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
June 2, 2026K261093DIAFILEBFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
May 19, 2026K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)EBFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
March 19, 2026K254112Dia-X Sil BiteELWSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
June 15, 2022K220804Dia-X Bond UniversalKLESubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
June 28, 2021K210421Diafil & Diafil CapsuleEBFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
March 25, 2021K210333DiaPasteKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
September 18, 2020K200174DIA-ROOT BIO MTAKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
August 7, 2020K200809D-LUX+EBZSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
June 25, 2020K200175DIA-ROOT BIO SealerKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
May 26, 2020K192392DiaPlusKLESubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
March 25, 2020K192284DiaFil FlowEBFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
March 20, 2020K192510DIAFIL & DIAFIL CapsuleEBFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
February 13, 2020K192158DiaTempEBGSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
February 13, 2020K192022DiaTemp FlowEBGSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
February 7, 2020K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitKLESubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
September 26, 2019K182009Dia-ProsealKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
June 3, 2019K182625Diapex PlusKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov

Compare with other makers

Updated September 16, 2026. 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.