Genoss Co., Ltd.
Medical device manufacturer in Suwon-Si, CN.
23510(k) clearances
0PMA approvals
0recalls
Device types
- EIH Powder, Porcelain 10
- LYC Bone Grafting Material, Synthetic 4
- EBF Material, Tooth Shade, Resin 2
- NPL Barrier, Animal Source, Intraoral 1
- ELB Scaler, Rotary 1
- KLE Agent, Tooth Bonding, Resin 1
- ELW Material, Impression 1
- KIF Resin, Root Canal Filling 1
- EKX Handpiece, Direct Drive, Ac-Powered 1
- EBZ Activator, Ultraviolet, For Polymerization 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242386 | BluemoonEBZ · Traditional | 05/05/2025SE |
| K222688 | The TrustEKX · Traditional | 08/09/2024SE |
| K233885 | rainbow Paste Stain SEEIH · Traditional | 06/21/2024SE |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoEIH · Traditional | 02/23/2024SE |
| K231480 | Bright MTA Sealer PlusKIF · Traditional | 07/28/2023SE |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | 12/15/2022SE |
| K200155 | Bright High FlowEBF · Traditional | 11/30/2020SE |
| K200153 | Bright Bond UniversalKLE · Traditional | 10/28/2020SE |
| K200156 | Bright Low FlowEBF · Traditional | 10/27/2020SE |
| K170596 | TN-BrushELB · Traditional | 09/11/2017SE |
| K160079 | rainbow ShineEIH · Traditional | 11/10/2016SE |
| K153676 | Osteon IIILYC · Traditional | 09/14/2016SE |
| K160144 | rainbow LS BlockEIH · Traditional | 07/21/2016SE |
| K151731 | Rainbow Paste StainEIH · Traditional | 04/15/2016SE |
| K151846 | Rainbow LS PressingEIH · Traditional | 01/14/2016SE |
| K151842 | Rainbow ShineEIH · Traditional | 01/14/2016SE |
| K151723 | Rainbow TransEIH · Traditional | 10/28/2015SE |
| K151844 | Rainbow ShadeEIH · Traditional | 10/16/2015SE |
| K112716 | Osteon IILYC · Traditional | 01/17/2012SE |
| K102307 | Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsNPL · Traditional | 05/04/2011SE |
| K102015 | Osteon, Osteon Sinus, Osteon LiftingLYC · Special | 11/19/2010SE |
| K092513 | Rainbow BlockEIH · Abbreviated | 10/09/2009SE |
| K062834 | Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050LYC · Abbreviated | 04/24/2007SE |