Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616128

FEI Number

3010138769

Entity Name

DIADENT GROUP INTERNATIONAL

City/State/Country

CHONGJU CITY Chungbuk, KR

Establishment Address

16, Osongsaengmyeong 4-Ro, Osong-Eup, HEUNGDUKGU, CHONGJU CITY Chungbuk 28161, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DiaDent Group International (Owner Number: 9033762)

Owner / Operator Contact Address

16, Osongsaengmyeong 4-Ro, Osong-Eup,, Heungdeok-Gu, CHONGJU CITY, KR-43 28161, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Steri. Irrigation Tips (Side Open Type) Disposable Tips Irrigation Tips (End Open Type) DiaPex Plus Dia-Ultrasonic DiaTemp ABSORBENT PAPER POINTS(STERII.E PAPER POINTS) Dia-100FS Dia-Cem Dia-Duo Duo-Gun Duo-Pen DIAFIL FLOW D-Lux+ DIA-PROSEAL DiaPaste DIAFIL START KIT DiaPlus DIA-ROOT BIO MTA GUTTA PERCHA POINTS GUTTA PERCHA OBTURATOR DIA-X BOND Universal DIACEM TEMPNE DiaPrep Pro DIA-ENDORING Endo Training Blocks Endo Shaping Blocks FILE MEASURE SET DIA-GP GAUGE ENDO STOPS DIRECTIONAL ASST DiaTemp Flow DIAFIL Bulk FLOW(Refill Package) DIAFIL Bulk FLOW (0.5g) DIAFIL Bulk FLOW Peeso Reamers Gate Drills DIA-ROOT BIO Sealer K-FILE (NICKEL-TITANIUM) Hedstrom Files H-FILE (NICKEL-TITANIUM) K-Files Reamers REAMER (NICKEL-TITANIUM) DIA-X FILE DIA-KONDENSOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2013-07-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2020-02-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-02-13
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2019-08-12
JET	Pick, Massaging	Dental	Class 1	872.6650	2023-02-19
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-02-13
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	1998-05-05
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2011-03-16
EMA	Cement, Dental	Dental	Class 2	872.3275	2023-10-11
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2009-09-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-03-25
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2020-09-02
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2019-09-26
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-03-30
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-07-29
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-07-29
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2020-06-02
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2020-10-05
EKM	Gutta-Percha	Dental	Class 1	872.3850	1998-05-05
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-08-08
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2022-03-29
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2011-03-16
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2014-04-25
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-02-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-05-20
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2017-04-18
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2020-07-06
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2011-03-16
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2013-07-08

Official Correspondent

No official correspondent registered.

US Agent Details

Jim MacNee Business: USDeviceAgent.com Email: Jmacnee@USDeviceAgent.com Phone: (951) 8486626

Related Public Records

Same Entity

DiaDent Group International

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3024787345	BATTECH	Irvine, CA, US
3031184338	ZHEJIANG LIDESEN MEDICAL INSTRUMENT CO., LTD	Hangzhou Zhejiang, CN
3007420701	Suzhou Fumaite Oral Care Products Co. Ltd.	Suzhou Jiangsu, CN
3024088964	READY SET IMPORT	Beverly Hills, CA, US
9615399	DIADENT GROUP INTL., INC.	Vancouver British Columbia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616128. Last updated year: 2026. Please use registration number 9616128 when referencing this establishment in official correspondence.