Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014980469

FEI Number

3014980469

Entity Name

OSSTEM IMPLANT CO., LTD.

City/State/Country

Siheung-si Gyeonggi, KR

Establishment Address

2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si Gyeonggi 15079, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Osstem Implant Co., Ltd. (Owner Number: 10058973)

Owner / Operator Contact Address

2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, KR-41 15079, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183475

PMA Number

N/A

All Registered Proprietary Names

T2 Plus (T2-C-P, T2-CS-P) N1 T2 (T2-C, T2-CS) SNAP Wireless SNAP Wired T1 C, T1-CS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2024-10-21
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2023-12-06
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2021-10-15
QJK	Intraoral Camera	Dental	Class 2	872.3661	2020-05-13
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2019-08-30

Official Correspondent

Hae Sung Kim

US Agent Details

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

Related Public Records

Same Entity

Osstem Implant Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3031886796	OSSTEM IMPLANT CO., LTD.	Gangseo-gu Seoul, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

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3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
9615832	OWANDY RADIOLOGY	CROISSY-BEAUBOURG Seine-et-Marne, FR
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3005383085	PALODEX GROUP OY	Tuusula Uusimaa, FI
3005843418	GENORAY CO., LTD.	Seongnam-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014980469. Last updated year: 2026. Please use registration number 3014980469 when referencing this establishment in official correspondence.