Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009528826

FEI Number

3009528826

Entity Name

DAEKWANG I.D.M

City/State/Country

Seoul, KR

Establishment Address

RM 802 8Fl, Woori bldg., 42, Chilpae-ro, Jung-gu, Seoul 04512, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DAEKWANG IDM (Owner Number: 10053764)

Owner / Operator Contact Address

RM 802, 42, Chilpae-ro,, Joong-gu, KR-11 04512, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112787

PMA Number

N/A

All Registered Proprietary Names

HANDLE, INSTRUMENT, DENTAL Abutment, implant, dental, endosseous

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2018-01-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-01-09

Official Correspondent

JEONGJOO JEON

US Agent Details

Yohan Kim Email: yohan@ossvis.com Phone: (747) 3504321

Related Public Records

Same Entity

DAEKWANG IDM

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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

Similar Registrations

Registration Number	Establishment Name	Location
3016954909	IMPLANT PROTESIS DENTAL 2004, S.L.	Premia de Dalt Barcelona, ES
3005972890	GoldenDent	Roseville, MI, US
3008808049	SURGICRAFTS	Sialkot Punjab, PK
3010583458	ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, CN
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009528826. Last updated year: 2026. Please use registration number 3009528826 when referencing this establishment in official correspondence.