Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015980207

FEI Number

3015980207

Entity Name

OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS

City/State/Country

Ansan-si Gyeonggi, KR

Establishment Address

192, Haebong-ro, Danwon-gu, Ansan-si Gyeonggi 15428, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Osstem Implant Co., Ltd. Chair Business (Owner Number: 10050476)

Owner / Operator Contact Address

192 Haebong-dong,Danwon-gu, Ansan-si, KR-41 15428, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

K5 S2 (digital intra-oral X-ray sensor) K5 Cart, K5 Mount, K5 Swing K3 K3-Chair only

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2024-10-21
KLC	Chair, Dental, With Operative Unit	Dental	Class 1	872.6250	2024-10-21
EAP	Unit, X-Ray, Intraoral	Dental	Class 2	872.1810	2026-01-08
KLC	Chair, Dental, With Operative Unit	Dental	Class 1	872.6250	2025-07-25
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2025-07-25
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2019-09-10
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2019-02-20

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. Chair Business

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 3015980207. Last updated year: 2026. Please use registration number 3015980207 when referencing this establishment in official correspondence.