Data / Medical devices / South Korea / Hdi Inc.

Hdi Inc.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 2 510(k) clearances

Name: Hdi Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hdi Inc. is registered with the FDA (registration 3025307990) in Seongnam-si Gyeonggi, South Korea. It lists 18 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 7, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3025307990
Address: A-504, 14, Sagimakgol-ro, 45beon-gil, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13209
Owner or operator: HDI Inc. (10086700)
Roles: Manufacturer
First device listed: December 4, 2022
Registered through: 2026
Brand names listed: DENU Composite Resin, DENU Flow Resin, DENU Heavy Body(Regular, Fast), DENU Light Body(Regular, Fast), DENU Putty Set(Regular, Fast), Denu Bite Block Cover, Denu Block-Out Resin, Denu Dam and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Manufacturer	accessdata.fda.gov
Applicator, Resin	KXR	1	Manufacturer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Floss, Dental	JES	1	Manufacturer	accessdata.fda.gov
Gag, Mouth	KBN	1	Manufacturer	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	1	Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Paper, Articulation	EFH	1	Manufacturer	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Manufacturer	accessdata.fda.gov
Protector, Dental	BRW	1	Manufacturer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Manufacturer	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 7, 2022	K222741	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)	ELW	Substantially Equivalent	Hdi, Inc.	accessdata.fda.gov
September 23, 2022	K213339	DENU Composite Resin, DENU Flow Resin	EBF	Substantially Equivalent	Hdi, Inc.	accessdata.fda.gov

Compare with other makers

Updated November 7, 2022. 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.