Nibec Co L T D

FDA Filings

This page includes the latest FDA filings for Nibec Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

138610

DUNS 687796909

FDA Registration(s)

• Registration Number: 3007679154
• FEI Number: 3007679154
• Name: NIBEC CO LTD
• Owner & Operator: NIBEC Co Ltd
• Contact Address: 116, Bamdi-gil, Iwol-myeon Jincheon-gun ; Jincheon KR-43 Chungcheongbugdo 27816 KR
• Official Correspondent:
  • Yoon Jeong Park
  • 82-43-5327458-x
• US Agent:
  • Lisa Conner
  • Industrial Science & Technology Network, Inc.
  • 717 5221739
  • 717 5221319
  • lconner@istninc.com
• Importing Logistics Registration:
  • Importer: Instradent USA, INC.
  • Address: 60 Minuteman Rd ; Andover, MA 01810 UNITED STATES
  • Email Address: jennifer.Jackson@straumann.com
  • Phone: 1 978 7472509 0
  • Importer Type: Retailer
• Importing Logistics Registration:
  • Importer: Smile US
  • Address: 22119 S.Vermont Ave. Torrance ; Torrance, CA 90502 UNITED STATES
  • Phone: 1 949 9453509 3509
  • Importer Type: Retailer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Iwol Electricity-electronic Agro-Industrial Complex 116 Bamdi-gil, Iwol-myeon; Jincheon-gun Chungcheongbugdo, 27816 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
Dr.Whitiss 15% NIBEC Co., Ltd., Nibec Co., Ltd	Otc Medication	2023-02-03
K-PURE NIBEC Co., Ltd.	Otc Medication	2021-01-29
K-PURE NIBEC Co., Ltd.	Otc Medication	2020-06-26
NDC 47649-0003 NIBEC Co., Ltd.	K-PURE	2020-06-10
Dr.Whitiss 15% NIBEC Co., Ltd., Nibec Co., Ltd	Otc Medication	2019-12-11
Dr.Whitiss 20% Nibec Co., Ltd	Otc Medication	2018-12-27
Dr.Whitiss 35% Nibec Co., Ltd	Otc Medication	2018-12-27
Dr.Whitiss 10% Nibec Co., Ltd	Otc Medication	2018-12-27
Dr.Whitiss 15% Nibec Co., Ltd	Otc Medication	2018-12-27
Clinplant Nibec Co., Ltd	Otc Medication	2018-07-19
NDC 47649-0002 Nibec Co., Ltd	Clinplant	2018-06-20
Dr. Whitiss (8.3%) Nibec Co., Ltd	Otc Medication	2017-11-28
PMN K150079 | NPM NIBEC CO LTD	Straumann Regenomer	2017-08-04
PMN K150079 | NPM NIBEC CO LTD	Regenomer	2017-08-04
PMN K142040 | NPM NIBEC CO LTD	Straumann XenoFlex	2016-01-18
PMN K142040 | NPM NIBEC CO LTD	OCS-B Collagen	2016-01-18
PMN K142040 | NPM NIBEC CO LTD	Creos Xenogain Collagen	2016-01-18
PMN K150079 NIBEC CO, LTD	Regenomer® Syringe, Regenomer® Plug, Regenomer® Block	2015-12-10
NDC 47649-1301 Nibec Co., Ltd	Dr.Whitiss 35%	2015-08-11
PMN K142040 NIBEC CO LTD	OCS-B COLLAGEN	2015-07-31
NDC 47649-1201 Nibec Co., Ltd	Dr.Whitiss 20%	2015-06-07
NDC 47649-1102 NIBEC Co., Ltd.	Dr.Whitiss 15%	2015-06-07
NDC 47649-1101 Nibec Co., Ltd	Dr.Whitiss 15%	2015-06-07
NDC 47649-0101 Nibec Co., Ltd	Dr.Whitiss 10%	2015-06-07
PMN K133507 | NPL NIBEC CO LTD	RegenoGide	2014-12-26
PMN K133507 | NPL NIBEC CO LTD	Instradent Membrane	2014-12-26
PMN K133507 | NPL NIBEC CO LTD	GuidOss	2014-12-26
PMN K133507 NIBEC CO LTD	GUIDOSS	2014-11-05
NDC 47649-9001 Nibec Co., Ltd	Dr. Whitiss (8.3%)	2014-07-11
PMN K113246 | NPM NIBEC CO LTD	Straumann XenoGraft	2013-07-18
PMN K113246 | NPM NIBEC CO LTD	OCS-B	2013-07-18
PMN K113246 | NPM NIBEC CO LTD	Neodent XenoGraft	2013-07-18
PMN K113246 | NPM NIBEC CO LTD	Instradent Xenograft	2013-07-18
PMN K113246 | NPM NIBEC CO LTD	Creos Xenogain	2013-07-18
PMN K113246 NIBEC COMPANY, LIMITED	OCS-B	2013-01-16
PMN K111816 | NPM NIBEC CO LTD	bone grafting material, animal source	2011-11-16