Data / Medical devices / South Korea / Innobiosurg Co., Ltd.

Innobiosurg Co., Ltd.: FDA-registered device maker in Daejeon, South Korea, 14 510(k) clearances

Name: Innobiosurg Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Innobiosurg Co., Ltd. is registered with the FDA (registration 3008309654) in Daejeon, South Korea. It lists 7 device types. The FDA files 14 510(k) clearances under its listings, the newest dated December 20, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008309654
Address: 44-19, Techno Street 10, YUSUNG-GU, Daejeon, South Korea, 305-500
Owner or operator: InnoBioSurg Co.,Ltd (10032324)
Roles: Manufacturer
First device listed: May 3, 2010
Registered through: 2026
Brand names listed: 1.2 Hexa Driver, 1.6 Lindemann Drill, AMII AMERICA KIT, AMII GPS Close Sleeve, AMII GPS Depth Drill, AMII GPS Digital KIT, AMII GPS Drill, AMII GPS Drill Tube and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Manufacturer	accessdata.fda.gov
Excavator, Dental, Operative	EKC	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 20, 2022	K220517	IBS System	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
December 14, 2022	K220079	Magicore Narrow System	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
October 15, 2021	K212517	Magicore System	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
August 25, 2021	K203344	Premilled Titanium Block System	NHA	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
December 3, 2020	K202418	Magic UCLA Abutment System	NHA	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
September 23, 2020	K202479	IBS Implant System	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
August 27, 2020	K201981	Magicore System	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
July 15, 2020	K201621	Magicore II System	NHA	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
June 9, 2020	K200753	IBS Implant System II	NHA	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
April 28, 2020	K192197	Magicore II System	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
March 16, 2018	K173120	CCM Abutment System	NHA	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
May 9, 2016	K153350	IBS Implant System	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
January 25, 2016	K152520	Magicore System	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov
March 23, 2015	K140806	IBS IMPLANT SYSTEM	DZE	Substantially Equivalent	Innobiosurg Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 20, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.