Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025307990

FEI Number

3025307990

Entity Name

HDI INC.

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

A-504, 14, Sagimakgol-ro, 45beon-gil, Jungwon-gu, Seongnam-si Gyeonggi 13209, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HDI Inc. (Owner Number: 10086700)

Owner / Operator Contact Address

A-1504, 14, Sagimakgol-ro, 45beon-gil, Jungwon-gu, Seongnam-si, KR-41 13209, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Denu Fil Flow Denu Dam Denu TemCement Cleaner Denu Ultra Cleaner Denu Suction Cleaner Denu Tray Cleaner Denu Fluoride Gel Tray Denu Plastic Probe DENU Heavy Body(Regular, Fast) DENU Light Body(Regular, Fast) DENU Putty Set(Regular, Fast) Denu Suction Plus Mouth Prop Denu Pumice Paste Denu Suction Plus Retractor DENU Flow Resin DENU Composite Resin Denu Jig Paste Denu Block-Out Resin Denu Jig Handy Denu TemTooth Denu GingiCord Denu EDTA Cream

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIE	Dam, Rubber	Dental	Class 1	872.6300	2023-06-23
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2023-06-23
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-06-23
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2023-06-23
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2023-06-23
ELW	Material, Impression	Dental	Class 2	872.3660	2022-12-04
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2023-06-23
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2023-06-23
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2023-06-23
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2022-12-04
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-12-04
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2023-06-23
JES	Floss, Dental	Dental	Class 1	872.6390	2023-06-13
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2023-06-23

Official Correspondent

Taekyou Kim

US Agent Details

Wen Wang Email: wen.wang@willowglenfda.com Phone: (619) 8690249

Related Public Records

Same Entity

HDI Inc.

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
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
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
3008475975	GLO Science, Inc.	Garden Grove, CA, US
3023895623	Jiangxi Ushine Bright Medical Co., Ltd.	Jiujiang City Jiangxi, CN
3009420946	HUANGHUA PROMISEE DENTAL CO., LTD	Huanghua Hebei, CN
1424442	PRIME DENTAL MANUFACTURING, INC.	CHICAGO, IL, US
3038632739	TF NEW MATERIAL SCI AND TEC CO.,LTD	Huainan Anhui, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025307990. Last updated year: 2026. Please use registration number 3025307990 when referencing this establishment in official correspondence.