Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710613

FEI Number

3000199218

Entity Name

SHINHUNG CO. LTD.

City/State/Country

Ansan-si Gyeonggi, KR

Establishment Address

42-25, 27beon-gil,, Dongsan-ro, Danwon-gu, Ansan-si Gyeonggi 15433, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHINHUNG CO. LTD. (Owner Number: 9046958)

Owner / Operator Contact Address

Shinhung Bldg, 450, Chongpa-ro, Jung-gu,, SEOUL, KR-NOTA 04510, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213749

PMA Number

N/A

All Registered Proprietary Names

ALU CROWN PERMA GOLDEN CROWN KIDS CROWN PERMA CROWN Primary Molar S.S. Crown KIDS ZIRCONIA CROWN Stainless Steel Primary Molar Crown KIDS GOLDEN CROWN, KIDS RING CROWN, KIDS ZIRCONIA CROWN TRY-IN K-CLAMP SHINJECT K-irrigator tips KF94 3D Mask Shinhung Dental Mask KF94 2D Mask G7, Dental Operative Unit and Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2009-04-02
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2012-09-25
DZM	Needle, Dental	Dental	Class 1	872.4730	2003-12-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2023-12-15
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2023-05-11

Official Correspondent

No official correspondent registered.

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

SHINHUNG CO. LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710613. Last updated year: 2026. Please use registration number 9710613 when referencing this establishment in official correspondence.