GENOSS Co., Ltd.
Suwon-si Gyeonggi, KR
GENOSS Co., Ltd. appears in FDA device records in Suwon-si Gyeonggi, KR. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for GENOSS Co., Ltd. between 2007 and 2025. The busiest year on record is 2016, with 6. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 2 |
| 2016 | 6 |
| 2017 | 1 |
| 2020 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242386 | Bluemoon | EBZ | Substantially Equivalent | |
| K222688 | The Trust | EKX | Substantially Equivalent | |
| K233885 | rainbow Paste Stain SE | EIH | Substantially Equivalent | |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | EIH | Substantially Equivalent | |
| K231480 | Bright MTA Sealer Plus | KIF | Substantially Equivalent | |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | ELW | Substantially Equivalent | |
| K200155 | Bright High Flow | EBF | Substantially Equivalent | |
| K200153 | Bright Bond Universal | KLE | Substantially Equivalent | |
| K200156 | Bright Low Flow | EBF | Substantially Equivalent | |
| K170596 | TN-Brush | ELB | Substantially Equivalent | |
| K160079 | rainbow Shine | EIH | Substantially Equivalent | |
| K153676 | OSTEON III | LYC | Substantially Equivalent | |
| K160144 | rainbow LS Block | EIH | Substantially Equivalent | |
| K151731 | Rainbow Paste Stain | EIH | Substantially Equivalent | |
| K151846 | Rainbow LS Pressing | EIH | Substantially Equivalent | |
| K151842 | Rainbow Shine | EIH | Substantially Equivalent | |
| K151723 | Rainbow Trans | EIH | Substantially Equivalent | |
| K151844 | Rainbow Shade | EIH | Substantially Equivalent | |
| K112716 | OSTEON II | LYC | Substantially Equivalent | |
| K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS | NPL | Substantially Equivalent | |
| K102015 | OSTEON, OSTEON SINUS, OSTEON LIFTING | LYC | Substantially Equivalent | |
| K092513 | RAINBOW BLOCK | EIH | Substantially Equivalent | |
| K062834 | OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 | LYC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006223010 | 3006223010 | GENOSS Co., Ltd. | 1201-1207, Gwanggyo business Center, 156, Gwanggyo-ro,, Suwon-si Gyeonggi 16229 KR | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- EBZActivator, Ultraviolet, For Polymerization
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- KLEAgent, Tooth Bonding, Resin
- NPLBarrier, Animal Source, Intraoral
- LYCBone Grafting Material, Synthetic
- EJLBur, Dental
- EMJElevator, Surgical, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- EIHPowder, Porcelain
- KIFResin, Root Canal Filling
- ELBScaler, Rotary
- PTMSyringe, Balloon Inflation, Exempt
- EHYTray, Impression, Preformed
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain