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

GENOSS Co., Ltd.: FDA-registered device maker in Suwon-si Gyeonggi, South Korea, 23 510(k) clearances

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

GENOSS Co., Ltd. is registered with the FDA (registration 3006223010) in Suwon-si Gyeonggi, South Korea. It lists 16 device types. The FDA files 23 510(k) clearances under its listings, the newest dated May 5, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006223010
Address: 1201-1207, Gwanggyo business Center, 156, Gwanggyo-ro, Yeongtong-gu, Suwon-si Gyeonggi, South Korea, 16229
Owner or operator: GENOSS Co., Ltd. (10023093)
Roles: Manufacturer
First device listed: November 5, 2007
Registered through: 2026
Brand names listed: 3B050510, 3B050530, 3B051010, 3B051015, 3B080810, 3G0205010, 3G0205025, 3G0205025L and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Manufacturer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Manufacturer	accessdata.fda.gov
Barrier, Animal Source, Intraoral	NPL	2	Manufacturer	accessdata.fda.gov
Bone Grafting Material, Synthetic	LYC	2	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Manufacturer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Manufacturer	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Manufacturer	accessdata.fda.gov
Scaler, Rotary	ELB	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	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
May 5, 2025	K242386	Bluemoon	EBZ	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
August 9, 2024	K222688	The Trust	EKX	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
June 21, 2024	K233885	rainbow Paste Stain SE	EIH	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
February 23, 2024	K232174	rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono	EIH	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
July 28, 2023	K231480	Bright MTA Sealer Plus	KIF	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
December 15, 2022	K214086	Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty	ELW	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
November 30, 2020	K200155	Bright High Flow	EBF	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
October 28, 2020	K200153	Bright Bond Universal	KLE	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
October 27, 2020	K200156	Bright Low Flow	EBF	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
September 11, 2017	K170596	TN-Brush	ELB	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
November 10, 2016	K160079	rainbow Shine	EIH	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
September 14, 2016	K153676	OSTEON III	LYC	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
July 21, 2016	K160144	rainbow LS Block	EIH	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
April 15, 2016	K151731	Rainbow Paste Stain	EIH	Substantially Equivalent	Genoss	accessdata.fda.gov
January 14, 2016	K151846	Rainbow LS Pressing	EIH	Substantially Equivalent	Genoss	accessdata.fda.gov
January 14, 2016	K151842	Rainbow Shine	EIH	Substantially Equivalent	Genoss	accessdata.fda.gov
October 28, 2015	K151723	Rainbow Trans	EIH	Substantially Equivalent	Genoss	accessdata.fda.gov
October 16, 2015	K151844	Rainbow Shade	EIH	Substantially Equivalent	Genoss	accessdata.fda.gov
January 17, 2012	K112716	OSTEON II	LYC	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
May 4, 2011	K102307	GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS	NPL	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
November 19, 2010	K102015	OSTEON, OSTEON SINUS, OSTEON LIFTING	LYC	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
October 9, 2009	K092513	RAINBOW BLOCK	EIH	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov
April 24, 2007	K062834	OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050	LYC	Substantially Equivalent	Genoss Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 5, 2025. 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.