Dental Device Guide
Add your company

Manufacturer registered with FDA

GENOSS Co., Ltd.

Suwon-si, South Korea. Lists 14 dental device types with FDA across 1 registered establishment, and holds 23 510(k) clearances as applicant.

FDA owner/operator10023093Manufacturer6 clearances in five years
Device types listed
14
Brands and models
3,793
510(k) clearances
232007–2025
Markets registered in
13202 registrations outside the US
Establishments
1South Korea
2007: 12009: 12010: 12011: 12012: 12015: 22016: 62017: 12020: 32022: 12023: 12024: 32025: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 13 markets

Where regulators' registries name GENOSS Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 14 device types listedEuropean Union: 108 registrationsTaiwan: 32 registrationsChina: 18 registrationsColombia: 16 registrationsSaudi Arabia: 12 registrationsPeru: 4 registrationsBrazil: 3 registrationsUnited Kingdom: 3 registrationsAustralia: 2 registrationsHong Kong: 2 registrationsCanada: 1 registrationsIsrael: 1 registrations
RegisteredHome: South KoreaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerGENOSS Co., Ltd.23 clearances2007–2025Below
European UnionEUDAMEDManufacturerGENOSS Co., Ltd.108—Pure Global AI
TaiwanTFDAManufacturerGenoss Co., Ltd.Genoss Co., Ltd · GENOSS CO., LTD.322008–2026Pure Global AI
ChinaNMPARegistration holder吉诺斯株式会社Genoss Co., Ltd.吉诺斯株式会社Genoss Co.,Ltd. · 吉诺斯株式会社GENOSS Co., Ltd. · +118—Pure Global AI
ColombiaINVIMARegistration holderGENOSS CO.LTD16—Pure Global AI
Saudi ArabiaSFDAManufacturerGenoss Co., Ltd.GENOSS Co., Ltd.12—Pure Global AI
PeruDIGEMIDManufacturerGENOSS CO., LTD.42022–2026Pure Global AI
BrazilANVISAManufacturerGENOSS CO.,LTD.32026–2026Pure Global AI
United KingdomMHRAManufacturerGenoss Co. Ltd.3—Pure Global AI
AustraliaTGAManufacturerGenoss Co Ltd22007–2025Pure Global AI
Hong KongMDDManufacturerGenoss Co., Ltd.22018–2018Pure Global AI
CanadaHealth CanadaRegistration holderGENOSS CO. LTD.12006–2006Pure Global AI
IsraelAMARManufacturerGenoss Co. Ltd.1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What GENOSS Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker
AMT0010A05AMT0010A1AMT0010A2AMT0010A3AMT0010A35AMT0010A4AMT0010EA1AMT0010EA2AMT0010EA3AMT0010EA35
3,465 more
AMT0010MA1AMT0010MA2AMT0010MA3AMT0010MA35AMT0012A05AMT0012A1AMT0012A2AMT0012A3AMT0012A35AMT0012A4AMT0012EA1AMT0012EA2AMT0012EA3AMT0012EA35AMT0012MA1AMT0012MA2AMT0012MA3AMT0012MA35AMT0014A05AMT0014A1AMT0014A2AMT0014A3AMT0014A35AMT0014A4AMT0014EA1AMT0014EA2AMT0014EA3AMT0014EA35AMT0014MA1AMT0014MA2AMT0014MA3AMT0014MA35AMT0016A05AMT0016A1AMT0016A2AMT0016A3AMT0016A35AMT0016A4AMT0016EA1AMT0016EA2AMT0016EA3AMT0016EA35AMT0016MA1AMT0016MA2AMT0016MA3AMT0016MA35AMT0018A05AMT0018A1AMT0018A2AMT0018A3AMT0018A35AMT0018A4AMT0018EA1AMT0018EA2AMT0018EA3AMT0018EA35AMT0018MA1AMT0018MA2AMT0018MA3AMT0018MA35AMT0020A05AMT0020A1AMT0020A2AMT0020A3AMT0020A35AMT0020A4AMT0020EA1AMT0020EA2AMT0020EA3AMT0020EA35AMT0020MA1AMT0020MA2AMT0020MA3AMT0020MA35AMT0022A05AMT0022A1AMT0022A2AMT0022A3AMT0022A35AMT0022A4AMT0022EA1AMT0022EA2AMT0022EA3AMT0022EA35AMT0022MA1AMT0022MA2AMT0022MA3AMT0022MA35AMT0024A05AMT0024A1AMT0024A2AMT0024A3AMT0024A35AMT0024A4AMT0024EA1AMT0024EA2AMT0024EA3AMT0024EA35AMT0024MA1AMT0024MA2AMT0024MA3AMT0024MA35AMT0025A05AMT0025A1AMT0025A2AMT0025A3AMT0025A35AMT0025A4AMT0025EA1AMT0025EA2AMT0025EA3AMT0025EA35AMT0025MA1AMT0025MA2AMT0025MA3AMT0025MA35AMT0026A05AMT0026A1AMT0026A2AMT0026A3AMT0026A35AMT0026A4AMT0026EA1AMT0026EA2AMT0026EA3AMT0026EA35AMT0026MA1AMT0026MA2AMT0026MA3AMT0026MA35AMT0028A05AMT0028A1AMT0028A2AMT0028A3AMT0028A35AMT0028A4AMT0028EA1AMT0028EA2AMT0028EA3AMT0028EA35
2009
Synthetic Bone Grafting MaterialLYC · Class 2Bone grafts & membranesMaker
DT7B0320DT7B0420DT7B0440DT7B0510DT7B0530DT7B0810DT7B0820DT7B0830DT7B1005DT7G0205025
112 more
DT7G0205025LSDT7G0205025SSDT7G0205050DT7G0205050LSDT7G0205050SSDT7G0205100DT7G0205200DT7G0205300DT7G0205400DT7G0205500DT7G0210025DT7G0210025LSDT7G0210025SSDT7G0210050DT7G0210050LSDT7G0210050SSDT7G0210100DT7G0210200DT7G0210300DT7G0210400DT7G0210500DT7G0510025DT7G0510025LSDT7G0510025SSDT7G0510050DT7G0510050LSDT7G0510050SSDT7G0510100DT7G0510200DT7G0510300DT7G0510400DT7G0510500DT7G1020025DT7G1020025LSDT7G1020025SSDT7G1020050DT7G1020050LSDT7G1020050SSDT7G1020100DT7G1020200DT7G1020300DT7G1020400DT7G1020500GBG0305GBG0305LGBG0305LSGBG0305SGBG0305SSGBG0310GBG0310LGBG0310LSGBG0310SGBG0310SSGBG0510GBG0510LGBG0510LSGBG0510SGBG0510SSGBG0520GBG0520LGBG0520LSGBG0520SGBG0520SSGBG1020GBG1020LGBG1020LSGBG1020SGBG1020SSGBG2030GBG3040GBG40503B0505103B0505303B0510103B0510153B0808103G02050103G02050253G0205025L3G0205025S3G02050503G0205050L3G0205050S3G02051003G02052003G02100103G02100253G0210025L3G0210025S3G02100503G0210050L3G0210050S3G02101003G02102003G05100103G05100253G0510025L3G0510025S3G05100503G0510050L3G0510050S3G05101003G05102003G10200103G10200253G1020025L3G1020025S3G10200503G1020050L3G1020050S3G10201003G1020200
2007
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
HFA0HFA1HFA2HFA3HFA3.5HFA4HFA5HFBWHFCVHFOA2
12 more
HFOA3LFA0LFA1LFA2LFA3LFA3.5LFA4LFA5LFBWLFCVLFOA2LFOA3
2020
Ultraviolet Activator for PolymerizationEBZ · Class 2Curing lightsMaker
GCL-01W
2025
Preformed Impression TrayEHY · Class 1Impression traysMaker
DBT-A-001DBT-A-002DBT-F-001DBT-P1-001DBT-P2-001DBT-P3-001
2023
Dental BurEJL · Class 1Dental burs & diamondsMaker
GRT063025GRT065030GRT085030GST083025PGSCKPGSSKXGD2060XGD2090XGD2360XGD2390
119 more
XGD2560XGD2590XGP2620SXGP2623SXGP2625SXGP3020SXGP3023SXGP3025SXGP3420SXGP3423SXGP3425SXGP3620SXGP3623SXGP3625SXGP3820SXGP3823SXGP3825SXGP4220SXGP4223SXGP4225SXGP4320SXGP4323SXGP4325SXGP4820SXGP4823SXGP4825SXGP5020SXGP5023SXGP5025SXPGS1926XPGS2634XPGS3425AXSG2635SXSG2640SXSG2645CXSG2645DXSG2645SXSG2650CXSG2650DXSG2655CXSG2660CXSG2670CXSG3035SXSG3040SXSG3045CXSG3045DXSG3045SXSG3050CXSG3050DXSG3055CXSG3060CXSG3070CXSG3435SXSG3440SXSG3445CXSG3445DXSG3445SXSG3450CXSG3450DXSG3455CXSG3460CXSG3470CXSG3635SXSG3640SXSG3645CXSG3645DXSG3645SXSG3650CXSG3650DXSG3655CXSG3660CXSG3670CXSG3835SXSG3840SXSG3845CXSG3845DXSG3845SXSG3850CXSG3850DXSG3855CXSG3860CXSG3870CXSG4235SXSG4240SXSG4245CXSG4245DXSG4245SXSG4250CXSG4250DXSG4255CXSG4260CXSG4270CXSG4335SXSG4340SXSG4345CXSG4345DXSG4345SXSG4350CXSG4350DXSG4355CXSG4360CXSG4370CXSG4835SXSG4840SXSG4845CXSG4845DXSG4845SXSG4850CXSG4850DXSG4855CXSG4860CXSG4870CXSG5035SXSG5040SXSG5045CXSG5045SXSG5050CXSG5060CXSG5070C
2014
Ac-Powered Direct Drive HandpieceEKX · Class 1Dental handpiecesMaker
TT-1
2025
Rotary ScalerELB · Class 2—Maker
TN-0.8TN-1TN-1.3
2017
Impression MaterialELW · Class 2Impression materialsMaker
DIM350PTF-02DIM50BT-01DIM50BT-04DIM50HB-01DIM50HB-04DIM50LBF-01DIM50LBF-04DIM50RBF-01DIM50RBF-04
2022
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker
GSB33GSB33BGSB34GSB34BGSB35GSB35BGSB38GSB38B
2014
Root Canal Filling ResinKIF · Class 2Root canal filling materialsMaker
MTA1
2023
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsMaker
BU6
2020
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
GPP162205GCGXDEGXHD25HGXHD25WGXPP162243
2018
Intraoral Animal Source BarrierNPL · Class 2Bone grafts & membranesMaker
GCM1020GCM1515GCM1520GCM2030GCM2530GCM3040GCT1220GCT1820GCT2420Straumann Membrane Plus
2011

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names GENOSS Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
5 May 2025K242386BluemoonEBZ Ultraviolet Activator for Polymerization
9 Aug 2024K222688The TrustEKX Ac-Powered Direct Drive Handpiece
21 Jun 2024K233885rainbow Paste Stain SEEIH Porcelain Powder
23 Feb 2024K232174rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoEIH Porcelain Powder
28 Jul 2023K231480Bright MTA Sealer PlusKIF Root Canal Filling Resin
15 Dec 2022K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-PuttyELW Impression Material
30 Nov 2020K200155Bright High FlowEBF Resin Tooth Shade Material
28 Oct 2020K200153Bright Bond UniversalKLE Resin Tooth Bonding Agent
27 Oct 2020K200156Bright Low FlowEBF Resin Tooth Shade Material
11 Sep 2017K170596TN-BrushELB Rotary Scaler
10 Nov 2016K160079rainbow ShineEIH Porcelain Powder
14 Sep 2016K153676OSTEON IIILYC Synthetic Bone Grafting Material
21 Jul 2016K160144rainbow LS BlockEIH Porcelain Powder
15 Apr 2016K151731Rainbow Paste StainEIH Porcelain Powder
14 Jan 2016K151846Rainbow LS PressingEIH Porcelain Powder
14 Jan 2016K151842Rainbow ShineEIH Porcelain Powder
28 Oct 2015K151723Rainbow TransEIH Porcelain Powder
16 Oct 2015K151844Rainbow ShadeEIH Porcelain Powder
17 Jan 2012K112716OSTEON IILYC Synthetic Bone Grafting Material
4 May 2011K102307GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELSNPL Intraoral Animal Source Barrier
19 Nov 2010K102015OSTEON, OSTEON SINUS, OSTEON LIFTINGLYC Synthetic Bone Grafting Material
9 Oct 2009K092513RAINBOW BLOCKEIH Porcelain Powder
24 Apr 2007K062834OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050LYC Synthetic Bone Grafting Material

Some of these clearances are listed with FDA today by another company: Institut Straumann AG (1), 韩国速压科技有限公司SOYAGREENTEC Co.,Ltd. (1).

Registered establishments

EstablishmentLocationWhat it does
GENOSS Co., Ltd.FDA reg. 3006223010Suwon-si Gyeonggi, South KoreaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10023093). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.