Dental Device Guide
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Registered with FDA

Diadent Group Intl., Inc.

Vancouver, Canada. Lists 23 dental device types with FDA across 1 registered establishment.

FDA owner/operator9035015Foreign exporterPrivate-label distributorRepacker / relabeler
Device types listed
23
Brands and models
55
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1Canada

Devices listed with FDA

What Diadent Group Intl., Inc. 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 compositesLister
DIAETCHDIAFILDIAFIL Bulk FLOWDIAFIL CapsuleDIAFIL Capsule TypeDIAFIL FLOWDIAFIL START KIT
2020
Root Canal Filling ResinKIF · Class 2Root canal filling materialsLister
DIA-PROSEALDIA-ROOT BIO MTADIA-ROOT BIO SealerDiaPasteDiaPex Plus
2019
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsLister
DIA-X BOND UniversalDIAETCHDIAFIL START KITDiaPlus
2020
Impression MaterialELW · Class 2Impression materialsLister
Dia-X Sil BiteDia-X Sil Heavy BodyDia-X Sil Light Body
2026
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsLister
DiaTempDiaTemp Flow
2020
Dental CementEMA · Class 2Dental cementsLister
DIA-CEM
2023
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsLister
Gate DrillsPeeso Reamers
2019
Mouth MirrorEAX · Class 1Dental hand instrumentsLister
Miracle Suction
2003
Ultraviolet Activator for PolymerizationEBZ · Class 2Curing lightsLister
D-Lux+
2020
Irrigating Endodontic Periodontic SyringeEIC · Class 1Dental hand instrumentsLister
DiaFlex
1998
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsLister
Cheek Retractors
2003
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsLister
DIA-ENDORINGDIA-GP GAUGEEndo Shaping BlocksENDO STOPS DIRECTIONAL ASSTEndo Training BlocksFILE MEASURE SET
2019
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsLister
Disposable Brushes
2019
Operative Amalgam and Foil CondenserEKG · Class 1Dental hand instrumentsLister
DIA-KONDENSOR
2019
Gutta-PerchaEKM · Class 1Root canal filling materialsLister
GUTTA PERCHA OBTURATORGUTTA PERCHA POINTS
2003
Endodontic Paper PointEKN · Class 1Root canal filling materialsLister
ABSORBENT PAPER POINTS(Sterile Paper Points)
2003
Root Canal Endodontic PreparerEKQ · Class 1Endodontic filesLister
DiaPrep Pro
2005
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsLister
Dia-DuoDuo-GunDuo-Pen
2003
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesLister
H-FILE (NICKEL-TITANIUM)Hedstrom FilesK-FILE (NICKEL-TITANIUM)K-FilesREAMER (NICKEL-TITANIUM)Reamers
2003
Endodontic BroachEKW · Class 1Endodontic filesLister
Barbed Broaches
2003
Zinc Oxide EugenolEMB · Class 1Dental cementsLister
DiaCemTempNE
2022
Massaging PickJET · Class 1Floss & interdental cleanersLister
Dia-Ultrasonic
2023
Oral Hygiene Rubber TipJEW · Class 1Floss & interdental cleanersLister
Disposable TipsIrrigation Tips (End Open Type)Steri. Irrigation Tips (Side Open Type)
2019

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

Also lists devices cleared under other names

Diadent Group Intl., Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: DiaDent Group International (22).

Decided510(k)DeviceApplicantDevice type
16 Sep 2026K254152Dia-X Sil Light BodyDiaDent Group InternationalELW Impression Material
16 Sep 2026K254142Dia-X Sil Heavy BodyDiaDent Group InternationalELW Impression Material
9 Jul 2026K261166DIA-CEMDiaDent Group InternationalEMA Dental Cement
2 Jun 2026K261093DIAFILDiaDent Group InternationalEBF Resin Tooth Shade Material
19 May 2026K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalEBF Resin Tooth Shade Material
19 Mar 2026K254112Dia-X Sil BiteDiaDent Group InternationalELW Impression Material
28 Jul 2023K231552Dia-CemDiaDent Group InternationalEMA Dental Cement
15 Jun 2022K220804Dia-X Bond UniversalDiaDent Group InternationalKLE Resin Tooth Bonding Agent
28 Jun 2021K210421Diafil & Diafil CapsuleDiaDent Group InternationalEBF Resin Tooth Shade Material
25 Mar 2021K210333DiaPasteDiaDent Group InternationalKIF Root Canal Filling Resin
18 Sep 2020K200174DIA-ROOT BIO MTADiaDent Group InternationalKIF Root Canal Filling Resin
7 Aug 2020K200809D-LUX+DiaDent Group InternationalEBZ Ultraviolet Activator for Polymerization
25 Jun 2020K200175DIA-ROOT BIO SealerDiaDent Group InternationalKIF Root Canal Filling Resin
26 May 2020K192392DiaPlusDiaDent Group InternationalKLE Resin Tooth Bonding Agent
27 Mar 2020K190091DiapasteDiaDent Group InternationalKIF Root Canal Filling Resin
25 Mar 2020K192284DiaFil FlowDiaDent Group InternationalEBF Resin Tooth Shade Material
20 Mar 2020K192510DIAFIL & DIAFIL CapsuleDiaDent Group InternationalEBF Resin Tooth Shade Material
13 Feb 2020K192158DiaTempDiaDent Group InternationalEBG Resin Temporary Crown and Bridge
13 Feb 2020K192022DiaTemp FlowDiaDent Group InternationalEBG Resin Temporary Crown and Bridge
7 Feb 2020K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitDiaDent Group InternationalKLE Resin Tooth Bonding Agent
26 Sep 2019K182009Dia-ProsealDiaDent Group InternationalKIF Root Canal Filling Resin
3 Jun 2019K182625Diapex PlusDiaDent Group InternationalKIF Root Canal Filling Resin

Registered establishments

EstablishmentLocationWhat it does
DIADENT GROUP INTL., INC.FDA reg. 9615399Vancouver British Columbia, CanadaForeign exporter, Private-label distributor, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9035015). 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.