Company ยท KR
Genoss Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EIH | Powder, Porcelain | 10 |
| LYC | Bone Grafting Material, Synthetic | 4 |
| EBF | Material, Tooth Shade, Resin | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 |
| ELB | Scaler, Rotary | 1 |
| ELW | Material, Impression | 1 |
| KIF | Resin, Root Canal Filling | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 |
| NPL | Barrier, Animal Source, Intraoral | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 2025 | K242386 | Bluemoon Genoss Co., Ltd., CN | EBZ |
| Aug 9, 2024 | K222688 | The Trust Genoss Co., Ltd., KR | EKX |
| Jun 21, 2024 | K233885 | rainbow Paste Stain SE Genoss Co., Ltd., KR | EIH |
| Feb 23, 2024 | K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono Genoss Co., Ltd., KR | EIH |
| Jul 28, 2023 | K231480 | Bright MTA Sealer Plus Genoss Co., Ltd., KR | KIF |
| Dec 15, 2022 | K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty Genoss Co., Ltd., KR | ELW |
| Nov 30, 2020 | K200155 | Bright High Flow Genoss Co., Ltd., KR | EBF |
| Oct 28, 2020 | K200153 | Bright Bond Universal Genoss Co., Ltd., KR | KLE |
| Oct 27, 2020 | K200156 | Bright Low Flow Genoss Co., Ltd., KR | EBF |
| Sep 11, 2017 | K170596 | TN-Brush Genoss Co., Ltd., KR | ELB |
| Nov 10, 2016 | K160079 | rainbow Shine Genoss Co., Ltd., KR | EIH |
| Sep 14, 2016 | K153676 | OSTEON III Genoss Co., Ltd., KR | LYC |
| Jul 21, 2016 | K160144 | rainbow LS Block Genoss Co., Ltd., KR | EIH |
| Apr 15, 2016 | K151731 | Rainbow Paste Stain Genoss, KR | EIH |
| Jan 14, 2016 | K151846 | Rainbow LS Pressing Genoss, KR | EIH |
| Jan 14, 2016 | K151842 | Rainbow Shine Genoss, KR | EIH |
| Oct 28, 2015 | K151723 | Rainbow Trans Genoss, KR | EIH |
| Oct 16, 2015 | K151844 | Rainbow Shade Genoss, KR | EIH |
| Jan 17, 2012 | K112716 | OSTEON II Genoss Co., Ltd., KR | LYC |
| May 4, 2011 | K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS Genoss Co., Ltd. | NPL |
| Nov 19, 2010 | K102015 | OSTEON, OSTEON SINUS, OSTEON LIFTING Genoss Co., Ltd. | LYC |
| Oct 9, 2009 | K092513 | RAINBOW BLOCK Genoss Co., Ltd. | EIH |
| Apr 24, 2007 | K062834 | OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 Genoss Co., Ltd. | LYC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||