Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021666765

FEI Number

3021666765

Entity Name

HUDENS BIO CO., LTD.

City/State/Country

Gwangju, KR

Establishment Address

318 Cheomdanyeonsin-ro, Buk-gu, Gwangju 61088, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HUDENS BIO CO., LTD. (Owner Number: 10095544)

Owner / Operator Contact Address

318 Cheomdanyeonsin-ro, Buk-gu, Gwangju, KR-29 61088, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251818

PMA Number

N/A

All Registered Proprietary Names

BONTREE PLUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2026-03-29

Official Correspondent

Hun Kim

US Agent Details

Kyungyoon Kang Business: K-Biotech Incorporated Email: kyungyoon.kang@kbiotechsolutions.com Phone: (408) 7507843

Related Public Records

Same Entity

HUDENS BIO 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
K052493	Steiner Laboratories	SOCKET GRAFT	2006-06-09

Similar Registrations

Registration Number	Establishment Name	Location
3004525100	SOYAGREENTEC CO.,LTD	Hwaseong-si Gyeonggi, KR
1058584	Sterigenics US LLC	Charlotte, NC, US
3021912300	OSTEOGENE TECH CORP	Norwood, NJ, US
3003300673	Collagen Matrix, Inc	Allendale, NJ, US
3003768919	NOVABONE PRODUCTS, LLC	ALACHUA, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021666765. Last updated year: 2026. Please use registration number 3021666765 when referencing this establishment in official correspondence.