Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017847628

FEI Number

3017847628

Entity Name

HYUNDAI BIOLAND CO., LTD.

City/State/Country

Cheongju-si Chungbuk, KR

Establishment Address

162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si Chungbuk 28125, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HYUNDAI BIOLAND Co., Ltd. (Owner Number: 10078950)

Owner / Operator Contact Address

162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, KR-43 28125, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200623

PMA Number

N/A

All Registered Proprietary Names

OssGuide OsteoFlex XP-SEAL OsseoSeal Oradapt T-Gen TBS Dental

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2020-11-11

Official Correspondent

Hee Joon Lee

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

HYUNDAI BIOLAND 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 3017847628. Last updated year: 2026. Please use registration number 3017847628 when referencing this establishment in official correspondence.