Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616142

FEI Number

3001421500

Entity Name

SURE DENT CORPORATION

City/State/Country

SEONGNAM-SI Gyeonggi, KR

Establishment Address

#809, 52, SAGIMAKGOL-RO, JUNGWON-GU, SEONGNAM-SI Gyeonggi 13210, KR

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SURE DENT CORPORATION (Owner Number: 9034040)

Owner / Operator Contact Address

#809, 52, SAGIMAKGOL-RO, JUNGWON-GU,, SEONGNAM-SI, KR-41 13210, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090992

PMA Number

N/A

All Registered Proprietary Names

GUTTA-PERCHA POINTS ABSORBENT PAPER POINT Sure-Prep Knit-Pak+ Cord (Premier Dental Products Co.) Sure-Cord Plus Sure-Paste

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKM	Gutta-Percha	Dental	Class 1	872.3850	1998-06-03
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	1998-06-03
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2024-06-04
MVL	Cord, Retraction	Unknown	Class U	N/A	2014-01-14
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2024-06-04

Official Correspondent

HOJIN BAE

US Agent Details

Elizabeth Kim Email: suredent@suredent.com Phone: (949) 8929465

Related Public Records

Same Entity

SURE DENT CORPORATION

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3004133229	TIANJIN DIADENT CO., LTD.	TIANJIN CITY, CN
3043750057	JIANGSU YIDA MEDICAL EQUIPMENT CO., LTD	Yancheng Jiangsu, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3005831677	B&L BIOTECH CO., INC	Ansan City Gyeonggi, KR
3042866301	HSG-S CORP	Savannah, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616142. Last updated year: 2026. Please use registration number 9616142 when referencing this establishment in official correspondence.