Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044779578

FEI Number

3044779578

Entity Name

SUMSEI CO., LTD.

City/State/Country

Seoul, KR

Establishment Address

104, Achasan-ro, Seongdong-gu, Seoul 04782, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SUMSEI CO., LTD. (Owner Number: 10095807)

Owner / Operator Contact Address

104, Achasan-ro, Seongdong-gu, Seoul, KR-11 04782, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wedent Tongue Cleaner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2026-05-01

Official Correspondent

Seungwoo Lee

US Agent Details

Joyce Kwon Business: PROVISION CONSULTING GROUP, INC. Email: ask@provisionfda.com Phone: (909) 4933276

Related Public Records

Same Entity

SUMSEI 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 3044779578. Last updated year: 2026. Please use registration number 3044779578 when referencing this establishment in official correspondence.