Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016445768

FEI Number

3016445768

Entity Name

Osstem Pharma Co., Ltd.

City/State/Country

Ansan-si Gyeonggi, KR

Establishment Address

Ga-Dong, Ra-Dong, 13, Neunggil-ro 115beon-gil, Danwon-gu, Ansan-si Gyeonggi 15420, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Osstem Pharma Co., Ltd. (Owner Number: 10062264)

Owner / Operator Contact Address

Ga-Dong, Ra-Dong, 13, Neunggil-ro 115beon-gil, Danwon-gu, Ansan-si, KR-41 15420, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WO-100 Sonic Electric Toothbrush Vussen Light Toothbrush Vussen Double-wide Toothbrush Osstem Double-wide Toothbrush Vussen Ultra Toothbrush WO-300 Osstem Wopick Combo Irrigator & Sonic Toothbrush WO-200 Osstem Wopick Cordless Oral Irrigator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-02-15
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2020-01-06
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-02-15

Official Correspondent

Byung chum Moon

US Agent Details

Martin Shin Business: HIOSSEN, Inc. Email: regulatoryaffairs@hiossen.com Phone: (267) 7106714

Related Public Records

Same Entity

Osstem Pharma 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

Similar Registrations

Registration Number	Establishment Name	Location
3015925939	EXPEDITORS	Surprise, AZ, US
3020145267	Shanghai Shi Mian De Electronic Products Co. Ltd.	Jinshan District Shanghai, CN
3029987245	FLAUS, INC.	New York, NY, US
3013257234	MINGZHEN (DONGGUAN) ELECTRONICS CO., LTD	Dongguan Guangdong, CN
3038200340	WEIFANG YANGXU LABOR PROTECTION PRODUCTS CO., LTD	Weifang Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016445768. Last updated year: 2026. Please use registration number 3016445768 when referencing this establishment in official correspondence.