Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032435508

FEI Number

3032435508

Entity Name

B&E KOREA CO., LTD.

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

995-16, Baran-ro, Jeongnam-myeon, Hwaseong-si Gyeonggi 18515, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

B&E KOREA Co., Ltd. (Owner Number: 10091760)

Owner / Operator Contact Address

995-16, Baran-ro, Jeongnam-myeon, Hwaseong-si, KR-41 18515, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233954

PMA Number

N/A

All Registered Proprietary Names

Chemi-SiL LB Chemi-SiL HB Chemi-SiL Bite-Blu

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2024-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

Eunjung Baek Email: Ejbaek@gmail.com Phone: (612) 9100253

Related Public Records

Same Entity

B&E KOREA Co., Ltd.

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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13

Similar Registrations

Registration Number	Establishment Name	Location
3030268763	OWL DENTAL	San Leandro, CA, US
8021038	VANNINI DENTAL INDUSTRY SRL	GRASSINA(FI) Firenze, IT
2018957	DEN-MAT HOLDINGS, LLC	Lompoc, CA, US
3005558160	MAXILL, INC.	ST. THOMAS Ontario, CA
9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032435508. Last updated year: 2026. Please use registration number 3032435508 when referencing this establishment in official correspondence.