Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007679154

FEI Number

3007679154

Entity Name

NIBEC CO LTD

City/State/Country

Jincheon-gun Chungbuk, KR

Establishment Address

Iwol Electricity-electronic Agro-Industrial Complex, 116 Bamdi-gil, Iwol-myeon, Jincheon-gun Chungbuk 27816, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NIBEC Co Ltd (Owner Number: 10038845)

Owner / Operator Contact Address

116, Bamdi-gil, Iwol-myeon Jincheon-gun, Jincheon, KR-43 27816, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133507

PMA Number

N/A

All Registered Proprietary Names

Regenomer Straumann Regenomer OCS-B Straumann XenoGraft Creos Xenogain Instradent Xenograft Neodent XenoGraft GuidOss RegenoGide Instradent Membrane

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2017-08-04
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2013-07-18
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2014-12-26

Official Correspondent

Yoon Jeong Park

US Agent Details

Lisa Conner Business: Industrial Science & Technology Network, Inc. Email: lconner@istninc.com Phone: (717) 5221739

Related Public Records

Same Entity

NIBEC 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 3007679154. Last updated year: 2026. Please use registration number 3007679154 when referencing this establishment in official correspondence.