Dental Device Guide
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Manufacturer registered with FDA

DiaDent Group International

CHONGJU CITY, South Korea. Lists 22 dental device types with FDA across 1 registered establishment, and holds 24 510(k) clearances as applicant.

FDA owner/operator9033762Foreign exporterManufacturerPrivate-label distributor9 clearances in five years
Device types listed
22
Brands and models
56
510(k) clearances
242013–2026
Markets registered in
151,123 registrations outside the US
Establishments
1South Korea
2013: 12019: 22020: 102021: 22022: 22023: 12026: 620102020

510(k) clearances per year, 2007–2026

Registered in 15 markets

Where regulators' registries name DiaDent Group International as the manufacturer or the registration holder of a device.

All markets
United States: 22 device types listedEuropean Union: 769 registrationsCanada: 187 registrationsSaudi Arabia: 38 registrationsTaiwan: 37 registrationsColombia: 23 registrationsAustralia: 19 registrationsSerbia: 12 registrationsBrazil: 7 registrationsHong Kong: 7 registrationsIsrael: 7 registrationsEgypt: 6 registrationsPeru: 4 registrationsUnited Kingdom: 4 registrationsChina: 3 registrations
RegisteredHome: South KoreaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDiaDent Group International24 clearances2013–2026Below
European UnionEUDAMEDManufacturerDIADENT GROUP INTERNATIONAL769—Pure Global AI
CanadaHealth CanadaRegistration holderDIADENT GROUP INTERNATIONAL1872004–2026Pure Global AI
Saudi ArabiaSFDAManufacturerDiadent Group InternationalDiaDent Group International38—Pure Global AI
TaiwanTFDAManufacturerDIADENT GROUP INTERNATIONALDiaDent Group International372005–2025Pure Global AI
ColombiaINVIMAManufacturerDIADENT GROUP INTERNATIONAL23—Pure Global AI
AustraliaTGAManufacturerDiadent Group International192008–2026Pure Global AI
SerbiaALIMSManufacturerDiaDent Group International122024–2024Pure Global AI
BrazilANVISAManufacturerDiaDent Group InternationalDIADENT GROUP INTERNATIONAL72015–2023Pure Global AI
Hong KongMDDManufacturerDiaDent Group InternationalDiadent Group International72025–2026Pure Global AI
IsraelAMARManufacturerDiaDent Group InternationalDiadent group international7—Pure Global AI
EgyptEDAManufacturerDiaDent Group International,62025–2026Pure Global AI
PeruDIGEMIDManufacturerDIADENT GROUP INTERNATIONAL42022–2024Pure Global AI
United KingdomMHRAManufacturerDiaDent Group International4—Pure Global AI
ChinaNMPARegistration holder迪牙登特国际集团公司DiaDent Group International3—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What DiaDent Group International currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
DIAFILDIAFIL Bulk FLOWDIAFIL CapsuleDIAFIL Capsule TypeDIAFIL FLOWDIAFIL START KIT
2020
Root Canal Filling ResinKIF · Class 2Root canal filling materialsMaker
DIA-PROSEALDIA-ROOT BIO MTADIA-ROOT BIO SealerDiaPasteDiaPex Plus
2019
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsMaker
DIA-X BOND UniversalDIAFIL START KITDiaPlus
2020
Impression MaterialELW · Class 2Impression materialsMaker
Dia-X Sil BiteDia-X Sil Heavy BodyDia-X Sil Light Body
2026
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsMaker
DiaTempDiaTemp Flow
2020
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsMaker
Gate DrillsPeeso Reamers
2017
Mouth MirrorEAX · Class 1Dental hand instrumentsLister
Miracle Suction
1998
Ultraviolet Activator for PolymerizationEBZ · Class 2Curing lightsMaker
D-Lux+
2020
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker
DIA-ENDORINGDIA-GP GAUGEEndo Shaping BlocksENDO STOPS DIRECTIONAL ASSTEndo Training BlocksFILE MEASURE SET
2014
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsLister
Disposable Brushes
2012
Operative Amalgam and Foil CondenserEKG · Class 1Dental hand instrumentsMaker
DIA-KONDENSOR
2013
Gutta-PerchaEKM · Class 1Root canal filling materialsMaker
GUTTA PERCHA OBTURATORGUTTA PERCHA POINTS
1998
Endodontic Paper PointEKN · Class 1Root canal filling materialsMaker
ABSORBENT PAPER POINTS(STERII.E PAPER POINTS)
1998
Root Canal Endodontic PreparerEKQ · Class 1Endodontic filesMaker
DiaPrep Pro
2011
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker
Dia-DuoDuo-GunDuo-Pen
2009
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesMaker
DIA-X FILEH-FILE (NICKEL-TITANIUM)Hedstrom FilesK-FILE (NICKEL-TITANIUM)K-FilesREAMER (NICKEL-TITANIUM)Reamers
2011
Endodontic BroachEKW · Class 1Endodontic filesMaker
Barbed Broaches
2015
Dental CementEMA · Class 2Dental cementsMaker
DIA-CEM
2026
Zinc Oxide EugenolEMB · Class 1Dental cementsMaker
DIACEM TEMPNE
2022
Massaging PickJET · Class 1Floss & interdental cleanersMaker
Dia-Ultrasonic
2023
Oral Hygiene Rubber TipJEW · Class 1Floss & interdental cleanersLister
Disposable TipsIrrigation Tips (End Open Type)Steri. Irrigation Tips (Side Open Type)
2013
Resin ApplicatorKXR · Class 1—Maker
Brush HandleBrush TipsMixing padMixing Well
2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names DiaDent Group International as the applicant.

Decided510(k)DeviceDevice type
16 Sep 2026K254152Dia-X Sil Light BodyELW Impression Material
16 Sep 2026K254142Dia-X Sil Heavy BodyELW Impression Material
9 Jul 2026K261166DIA-CEMEMA Dental Cement
2 Jun 2026K261093DIAFILEBF Resin Tooth Shade Material
19 May 2026K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)EBF Resin Tooth Shade Material
19 Mar 2026K254112Dia-X Sil BiteELW Impression Material
28 Jul 2023K231552Dia-CemEMA Dental Cement
15 Jun 2022K220804Dia-X Bond UniversalKLE Resin Tooth Bonding Agent
31 Jan 2022K213401DIAPLUS UniversalKLE Resin Tooth Bonding Agent
28 Jun 2021K210421Diafil & Diafil CapsuleEBF Resin Tooth Shade Material
25 Mar 2021K210333DiaPasteKIF Root Canal Filling Resin
18 Sep 2020K200174DIA-ROOT BIO MTAKIF Root Canal Filling Resin
7 Aug 2020K200809D-LUX+EBZ Ultraviolet Activator for Polymerization
25 Jun 2020K200175DIA-ROOT BIO SealerKIF Root Canal Filling Resin
26 May 2020K192392DiaPlusKLE Resin Tooth Bonding Agent
27 Mar 2020K190091DiapasteKIF Root Canal Filling Resin
25 Mar 2020K192284DiaFil FlowEBF Resin Tooth Shade Material
20 Mar 2020K192510DIAFIL & DIAFIL CapsuleEBF Resin Tooth Shade Material
13 Feb 2020K192158DiaTempEBG Resin Temporary Crown and Bridge
13 Feb 2020K192022DiaTemp FlowEBG Resin Temporary Crown and Bridge
7 Feb 2020K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitKLE Resin Tooth Bonding Agent
26 Sep 2019K182009Dia-ProsealKIF Root Canal Filling Resin
3 Jun 2019K182625Diapex PlusKIF Root Canal Filling Resin
16 Aug 2013K130163D-LUXEBZ Ultraviolet Activator for Polymerization

Registered establishments

EstablishmentLocationWhat it does
DIADENT GROUP INTERNATIONALFDA reg. 9616128CHONGJU CITY Chungbuk, South KoreaForeign exporter, Manufacturer, Private-label distributor

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9033762). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.