Manufacturer registered with FDA
Izenimplant Co., Ltd.
Pyeongtaek-si, South Korea. Lists 4 dental device types with FDA across 2 registered establishments, and holds 8 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 208
- 510(k) clearances
- 82022–2026
- Markets registered in
- 572 registrations outside the US
- Establishments
- 2South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Izenimplant Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Izenimplant Co., Ltd. | 8 clearances | 2022–2026 | Below |
| European Union | EUDAMED | Manufacturer | Izenimplant Co.,Ltd | 65 | — | Pure Global AI |
| China | NMPA | Registration holder | 爱瑧种植牙株式会社Izenimplant Co., Ltd. | 3 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Izenimplant Co., Ltd., | 3 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Izenimplant CO., LTD. | 1 | 2024–2024 | 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 Izenimplant Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ZENEX Implant SystemZENEX Implant System_LongZENEX Implant System_NarrowZENEX Implant System_R-SystemZENEX Implant System_ShortZENEX Implant System_Short (R-System) | 2022 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Ti Link AbutmentZENEX FreeMilling & CCM Cast AbutmentZENEX Implant SystemZENEX Implant System_NarrowZENEX Implant System_R-System | 2022 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Bone Profiler (Model: SBP41, SBP46, SBP56, SBP76)BT Profiler for Healing Abutment (Model: BTP50M, BTP50R)Cortical Drill (Model: CD3FXF30, CD3FNF30, CD4FF35, CD4FF40, CD4FF45, CD4FF50, CD4FF55, CD4FF60, CD4FF70)Dental T-Shaper (Model: DTSD18)Drill for Orthodontic (Model: D10OTC, D13OTC, D15OTC)Guide Drill (Model: GD3F20L, GD3F20S, GD3F25S, GD3F25L, GDN3F20S, GDN3F20L)Guide Drill (Non-stopper) (Model: GDN3F20S, GDN3F20L)Lindemann Drill (Model: LD4F25L, LD4F20S, LD4F20L, LD4F25S, LD4F35M)Point drill (Model: PDN3F20S, PDN3F20L)Short Drill (Model: SD4F45, SD4F49, SD4F53, SD4F57, SD4F66) 41 moreShort Step Drill (Model: SSD2F22, SPD4F40)Step Drill (Model: TD2F2206, TD2F2207, TD2F2208, TD2F2210, TD2F2211, TD2F2213, TD2F2215, TD2F2506, TD2F2507, TD2F2508)Step Drill (Model: TD2F3606, TD2F3607, TD2F3608, TD2F3610, TD2F3611, TD2F3613, TD2F3615, TD2F3618, TD2F3620, TD2F4106)Step Drill (Model: TD2F4107, TD2F4108, TD2F4110, TD2F4111, TD2F4113, TD2F4115, TD2F4118, TD2F4120, TD2F4606, TD2F4607)Step Drill (Model: TD2F4608, TD2F4610, TD2F4611, TD2F4613, TD2F4615, TD3F5206, TD3F5207, TD3F5208, TD3F5210, TD3F5211)Step Drill (Model: TD3F5213, TD3F5215, TD3F5506, TD3F5507, TD3F5508, TD3F5510, TD3F5511, TD3F5513, TD3F5515, TD3F6213)Step Drill (Model: TD3F6506, TD3F6507, TD3F6508, TD3F6510, TD3F6511, TD3F6513, TD2F2218, TD2F2220)Tap Drill (Model: TD4FF50, TD4FF45, TD4FF40, TD4FF35)Taper Cortical Drill (Model: TACD4FF55, TACD4FF35, TACD4FF40, TACD4FF45, TACD4FF50)Taper Drill (Model Name: TAD3F4511, TAD3F4513, TAD3F4515, TAD3F5006, TAD3F5007, TAD3F5008, TAD3F5010, TAD3F5011)Taper Drill (Model Name: TAD3F5013, TAD3F5015, TAD3F5506, TAD3F5507, TAD3F5508, TAD3F5510, TAD3F5511, TAD3F5513)Taper Drill (Model Name: TAD3F5515)Taper Drill (Model: TAD3F3506, TAD3F3507, TAD3F3508, TAD3F3510, TAD3F3511, TAD3F3513, TAD3F3515, TAD3F4006, TAD3F4007)Taper Drill (Model: TAD3F4008, TAD3F4010, TAD3F4011, TAD3F4013, TAD3F4015, TAD3F4506, TAD3F4507, TAD3F4508, TAD3F4510)Tissue Punch (Model: TP3308, TP3808, TP4308, TP4808, TP5308)Trephine Drill (Model: TD4218, TD5218, TD3718, TD4718, TD5718, TD6218)Twist Drill (Model: TD2F22S, TD2F22L, TD2F25L, TD2F27L, TD2F30S, TD2F30L, TD2F36S, TD2F36L, TD2F41S, TD2F41L, TD2F46S)Twist Drill (Model: TD2F46L, TD2F25S, TD2F27S, TDM2F22L, TDM2F25L, TDM2F27L, TDM2F30L, TD3F30S, TD3F36S, TD3F41S)Twist Drill (Model: TD3F30S, TD3F30L, TD3F36S, TD3F36L, TD3F41S, TD3F41L, TD3F46S, TD3F46L)Twist Drill (Model: TD3F46S, TD3F30L, TD3F36L, TD3F41L, TD3F46L, TDM3F25L, TDM3F27L, TDM3F30L)Twist Drill (Non-stopper) (Model: TDN3F46S, TDN3F46L, TDN3F41S, TDN3F41L, TDN3F36S, TDN3F36L, TDN3F30S, TDN3F30L)ZENEX Guide Anchor Drill (Model: ZGAD13)ZENEX Guide Cortical Drill (Model: ZGCDF35M)ZENEX Guide Cortical Drill (Model: ZGCDF35R, ZGCDF40R, ZGCDF45R, ZGCDF50R, ZGCDF70W, ZGCDF60W, ZGCDF50W, ZGCDNF30M)ZENEX Guide Flattening Drill (Model: ZGFD3712M, ZGFD4609R, ZGFD4610R, ZGFD4612R, ZGFD5209W, ZGFD3512M, ZGFD4709R)ZENEX Guide Flattening Drill (Model: ZGFD4710R, ZGFD4712R, ZGFD6309W)ZENEX Guide Initial Drill (Model: ZGID2204R, ZGID2207R, ZGID2208R, ZGID2210R, ZGID2211R, ZGID2213R, ZGID2205M)ZENEX Guide Initial Drill (Model: ZGID2218R, ZGID2220R)ZENEX Guide Start Drill (Model: ZGSD30R, ZGSD36R, ZGSD41R, ZGSD46R)ZENEX Guide Tissue Punch (Model: ZGTP3808R, ZGTP4308R, ZGTP4808R, ZGTP5308R, ZGTP3808M, ZGTP6007W)ZENEX Guide Twist Drill (Model: ZGTD2708M, ZGTD2710M, ZGTD2711M, ZGTD2713M, ZGTD2715M, ZGTD3008M, ZGTD3010M, ZGTD3011M)ZENEX Guide Twist Drill (Model: ZGTD3005W, ZGTD3006W, ZGTD3007W, ZGTD3008W, ZGTD3010W, ZGTD3011W, ZGTD5505W, ZGTD5506W)ZENEX Guide Twist Drill (Model: ZGTD3013M, ZGTD3015M, ZGTD3005R, ZGTD3007R, ZGTD3008R, ZGTD3010R, ZGTD3011R, ZGTD3013R)ZENEX Guide Twist Drill (Model: ZGTD3015R, ZGTD3605R, ZGTD3607R, ZGTD3608R, ZGTD3610R, ZGTD3611R, ZGTD3613R, ZGTD3615R)ZENEX Guide Twist Drill (Model: ZGTD3018R, ZGTD3020R, ZGTD3618R, ZGTD3620R, ZGTD4118R, ZGTD4120R)ZENEX Guide Twist Drill (Model: ZGTD4105R, ZGTD4107R, ZGTD4108R, ZGTD4110R, ZGTD4111R, ZGTD4113R, ZGTD4115R, ZGTD4605R)ZENEX Guide Twist Drill (Model: ZGTD4607R, ZGTD4608R, ZGTD4610R, ZGTD4611R, ZGTD4613R, ZGTD4615R, ZGTD4605W, ZGTD4606W)ZENEX Guide Twist Drill (Model: ZGTD4607W, ZGTD4608W, ZGTD4610W, ZGTD4611W)ZENEX Guide Twist Drill (Model: ZGTD5507W, ZGTD5508W, ZGTD5510W, ZGTD5511W, ZGTD6505W, ZGTD6506W, ZGTD6507W, ZGTD6508W)ZENEX Guide Twist Drill (Model: ZGTD6510W, ZGTD6511W, ZGTD3018R, ZGTD3020R, ZGTD3618R, ZGTD3620R, ZGTD4118R, ZGTD4120R)1.2 Hex Angled Machine Screw Driver (Model: HEADM1215, HEADM1220) | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Remover (Model: ARRM18)Abutment Remover (Model: ARRM18L)All in One Mount (Model: AOMRR23S, AOMRR23L)All in One Mount (Model: AOMSX17S, AOMSX17L, AOMSR25S, AOMSR25L, AOMTM21S, AOMTM21L, AOMTR25S, AOMTR25L)Ball Abutment Driver (Model: BAD24)Ball Abutment Lab Analog (Model: BAALA)Ball Abutment Lab O-ring (Model: BASRLO)Ball Abutment O-ring (Model: BASRR)Bite Impression Coping (Model: BICRR5043, BICRR5044, BICRR5045, BICRR5064, BICRR5065, BICRR5066, BICRR6043, BICRR6044)Bite Impression Coping (Model: BICRR6045, BICRR6064, BICRR6065, BICRR6066, BICRR7043, BICRR7044, BICRR7045, BICRR7064) 136 moreBite Impression Coping (Model: BICRR7065, BICRR7066)Bite Impression Coping (Model: BICSR4043, BICSR4044, BICSR4045, BICSR4064, BICSR4065, BICSR4066, BICSR4542, BICSR4543)Bite Impression Coping (Model: BICSR4544, BICSR4545, BICSR4564, BICSR4565, BICSR4566, BICSR5242, BICSR5243, BICSR5244)Bite Impression Coping (Model: BICSR5245, BICSR5264, BICSR5265, BICSR5266, BICSR5743, BICSR5744, BICSR5745, BICSR5764)Bite Impression Coping (Model: BICSR5765, BICSR5766, BICSR6543, BICSR6544, BICSR6545, BICSR6564, BICSR6565, BICSR6566)Bite Impression Coping (Model: BICTM4042, BICTM4043, BICTM4044, BICTM4064, BICTM4066, BICTM4542, BICTM4543, BICTM4544)Bite Impression Coping (Model: BICTR4545, BICTR4564, BICTR4565, BICTR4566, BICTR5042, BICTR5043, BICTR5044, BICTR5045)Bite Impression Coping (Model: BICTR5064, BICTR5065, BICTR5066, BICTR6043, BICTR6044, BICTR6045, BICTR6064, BICTR6065)Bite Impression Coping (Model: BICTR6066, BICTR7043, BICTR7044, BICTR7045, BICTR7064, BICTR7065, BICTR7066, BICSX4042)Bite Impression Coping Driver (Model: BICD50LS, BICD50SS, BICD40LS, BICD40SS)Bite Impression Coping Guide Pin (Model: BIGPRR66, BIGPSR43, BIGPSR44, BIGPTM42, BIGPTM43, BIGPTM44, BIGPTM64, BIGPTM66)Bite Impression Coping Guide Pin (Model: BIGPSR42, BIGPSR45, BIGPSR64, BIGPSR65, BIGPSR66, BIGPSX42, BIGPSX43, BIGPSX44)Bite Impression Coping Guide Pin (Model: BIGPSX64, BIGPSX66, BIGPRR42, BIGPRR43, BIGPRR44, BIGPRR45, BIGPRR64, BIGPRR65)Bite Impression Coping Guide Pin (Model: BIGPTR42, BIGPTR43, BIGPTR44, BIGPTR45, BIGPTR64, BIGPTR65, BIGPTR66)Bite Impression Coping Set (Model: BICRR4045S, BICRR4064S, BICRR4044S, BICRR4043S, BICRR4042S, BICSR6566S, BICSR6565S)Bite Impression Coping Set (Model: BICRR5045S, BICRR5064S, BICRR5044S, BICRR5043S, BICRR5042S, BICRR4066S, BICRR4065S)Bite Impression Coping Set (Model: BICRR6065S, BICRR6045S, BICRR6064S, BICRR6044S, BICRR6043S, BICRR5066S, BICRR5065S)Bite Impression Coping Set (Model: BICRR7066S, BICRR7065S, BICRR7045S, BICRR7064S, BICRR7044S, BICRR7043S, BICRR6066S)Bite Impression Coping Set (Model: BICSR5764S, BICSR5744S, BICSR5743S, BICSR5266S, BICSR5265S, BICSR5245S, BICSR5264S)Bite Impression Coping Set (Model: BICSR6545S, BICSR6564S, BICSR6544S, BICSR6543S, BICSR5766S, BICSR5765S, BICSR5745S)Bone Profiler Guide Screw (Model: SBPGSSX14, SBPGSSN20, SBPGSSM20, SBPGSSR20, SBPGSTM20, SBPGSRM18, SBPGSRR18)Depth Gauge (Model: DG1720)Direction Pin (Model: DPSX3510, DPSN3510, DPSM3510, DPSR4509, DPTM4010, DPRR4009)Drill Extension (Model: DE4513)Drill Stopper (Model: TDDS03B, TDDS04P, TDDS05Y, TDDS06G, TDDS07B, TDDS08P, TDDS10Y, TDDS11G, TDDS13B, TDDS15P, TDDSM15PDrill Stopper (Model: TDDSM13B, TDDSM11G, TDDSM10Y, TDDSM08P)Drill Stopper Holder (Model: TDDSH60)Driver Shaft for Contra Angle Anchor Type (Model: DSCA20JTNP, DSCA20JTCP)Driver Shaft for Contra Angle O-ring Type (Model: DSCA20JBN, DSCA20JTN, DSCA20WBN, DSCA20OBN, DSCA20SBN, DSCA40JBN)Driver Shaft for Contra Angle O-ring Type (Model: DSCA40JTN, DSCA40WBN, DSCA40OBN, DSCA40SBN)Finger Driver for Driver Shaft (Model: FDDS100)Fixture Driver for Contra Angle (Model: FDCRR23L)Fixture Driver for Contra Angle (Model: FDCSX17L, FDCSR25S, FDCSR25L, FDCTM21S, FDCTM21L, FDCTR25S, FDCTR25L, FDCRR23S)Fixture Driver for Ratchet (Model: FDRSX1720, FDRSR2520, FDRTM2120, FDRTR2520, FDRRR2320)Fixture Lab Analog (Model: FLASX300, FLASN300, FLASM350, FLASR400)Lab Driver Set (Model: LD4S)Mount Driver (Model: MDCAS, MDRAS)Multi Angled Abutment Carrier (Model: MAACRMC)Multi Healing Cap (Model: MHCSR48)Multi Lab Analog (Model: MLASR48)Multi Pick-up Impression Coping (Model: MPICSR48, MTPICSR48)Multi Pick-up Impression Coping Guide Pin (Model: MPICSRGP, MPICSRGPL, MTPICSRGP, MTPICSRGPL)Multi Plastic Cast Cylinder (Model: MPCCSRN48)Multi ScanBody (Model: MSBSR4809)Multi ScanBody Screw (Model: MSBSRS14)Multi Straight Abutment Carrier (Model: MSACR48)Multi Straight Abutment Driver (Model: MSADSR20, MSADSC20)Multi Transfer Impression Coping (Model: MTICSR48)Parallel Pin (Model: PP351822, PP501822)Pick-up Impression Coping (Model: PIRRH60S, PIRRH60L, PIRRH70S, PIRRH70L, PIRRN40S, PIRRN40L, PIRRN50S, PIRRN50L)Pick-up Impression Coping (Model: PIRRN60S, PIRRN60L, PIRRN70S, PIRRN70L)Pick-up Impression Coping (Model: PISRH45L, PISRH52L, PISRH57L, PISRH65L, PISXN40S, PISXN40L, PISRN40S, PISRN45S)Pick-up Impression Coping (Model: PISXH40S, PISXH40L, PISRH40S, PISRH45S, PISRH52S, PISRH57S, PISRH65S, PISRH40L)Pick-up Impression Coping (Model: PITMH40S, PITMH45S, PITMH40L, PITMH45L, PITRH40S, PITRH45S, PITRH50S, PITRH60S)Pick-up Impression Coping (Model: PITMN40L, PITMN45L, PITRN40S, PITRN45S, PITRN50S, PITRN60S, PITRN70S, PITRN40L)Pick-up Impression Coping (Model: PITRH70S, PITRH40L, PITRH45L, PITRH50L, PITRH60L, PITRH70L, PITMN40S, PITMN45S)Pick-up Impression Coping (Model: PITRN45L, PITRN50L, PITRN60L, PITRN70L, PIRRH40S, PIRRH40L, PIRRH50S, PIRRH50L)Pick-up Impression Coping (Model:PISRN52S, PISRN57S, PISRN65S, PISRN40L, PISRN45L, PISRN52L, PISRN57L, PISRN65L)Pick-up Impression Coping Guide Pin (Model: PIGPRRS, PIGPRRL)Pick-up Impression Coping Guide Pin (Model: PIGPSXS, PIGPSXL, PIGPSRS, PIGPSRL, PIGPTMS, PIGPTML, PIGPTRS, PIGPTRL)Pick-up Impression Coping Set (Model: PISRH40SS, PISXH40LS, PISXH40SS)Pick-up Impression Coping Set (Model: PISRH52LS, PISRH45LS, PISRH40LS, PISRH65SS, PISRH57SS, PISRH52SS, PISRH45SS)Pick-up Impression Coping Set (Model: PISRN52SS, PISRN45SS, PISRN40SS, PISXN40LS, PISXN40SS, PISRH65LS, PISRH57LS)Pick-up Impression Coping Set (Model: PISRN65LS, PISRN57LS, PISRN52LS, PISRN45LS, PISRN40LS, PISRN65SS, PISRN57SS)Pick-up Impression Coping Set (Model: PITRH50SS, PITRH45SS, PITRH40SS, PITMH45LS, PITMH40LS, PITMH45SS, PITMH40SS)Pick-up Impression Coping Set (Model: PITRH70LS, PITRH60LS, PITRH50LS, PITRH45LS, PITRH40LS, PITRH70SS, PITRH60SS)Pick-up Impression Coping Set (Model: PITRN50SS, PITRN45SS, PITRN40SS, PITMN45LS, PITMN40LS, PITMN45SS, PITMN40SS)Pick-up Impression Coping Set (Model: PITRN70LS, PITRN60LS, PITRN50LS, PITRN45LS, PITRN40LS, PITRN70SS, PITRN60SS)Prosthetic Driver Full KIT (Model: PDFK)Prosthetic Driver KIT (Model: PDK)Reverse Scanbody (Model: MRSBSR48, RSBSM3512, RSBSR4012, RSBRR3512, RSBTM3512, RSBTR4012)ScanBody (Model: IRSBR4310, IISBM4214, IISBR4410, ITSBM4114, ITSBR4510)ScanBody Screw (Model: ISBSM4014, ISBSR4310, TSBSM4014, TSBSR4310, RSBSR4310)Screw Driver Connector (Model: TSDH80C)Screw Driver Holder (Model: TSDH150)SCS Driver for Ratchet (Model: SCDR1710, SCDR1715, SCDR1725)SCS Lab Driver (Model: SCLD1725)Shank Driver (Model: SD70)Slot Driver for Ratchet (Model: SLDR0510, SLDR0515, SLDR0525)Steel Bowl (Model: STBOWL)Torque Wrench (Model: TW60B)Transfer Impression Coping (Model: TIRRH60S, TIRRH60L, TIRRH70S, TIRRH70L, TIRRN40S, TIRRN40L, TIRRN50S, TIRRN50L)Transfer Impression Coping (Model: TIRRN60S, TIRRN60L, TIRRN70S, TIRRN70L)Transfer Impression Coping (Model: TISRH45L, TISRH52L, TISRH57L, TISRH65L, TISXN40S, TISXN40L, TISRN40S, TISRN45S)Transfer Impression Coping (Model: TISRN52S, TISRN57S, TISRN65S, TISRN40L, TISRN45L, TISRN52L, TISRN57L, TISRN65L)Transfer Impression Coping (Model: TISXH40S, TISXH40L, TISRH40S, TISRH45S, TISRH52S, TISRH57S, TISRH65S, TISRH40L)Transfer Impression Coping (Model: TITMH40S, TITMH45S, TITMH40L, TITMH45L, TITRH40S, TITRH45S, TITRH50S, TITRH60S)Transfer Impression Coping (Model: TITMN40L, TITMN45L, TITRN40S, TITRN45S, TITRN50S, TITRN60S, TITRN70S, TITRN40L)Transfer Impression Coping (Model: TITRH70S, TITRH40L, TITRH45L, TITRH50L, TITRH60L, TITRH70L, TITMN40S, TITMN45S)Transfer Impression Coping (Model: TITRN45L, TITRN50L, TITRN60L, TITRN70L, TIRRH40S, TIRRH40L, TIRRH50S, TIRRH50L)Transfer Impression Coping Guide Pin (Model: TIGPRRS, TIGPRRL)Transfer Impression Coping Guide Pin (Model: TIGPSXS, TIGPSXL, TIGPSRS, TIGPSRL, TIGPTMS, TIGPTML, TIGPTRS, TIGPTRL)Transfer Impression Coping Set (Model: TISRH40SS, TISXH40LS, TISXH40SS)Transfer Impression Coping Set (Model: TISRH52LS, TISRH45LS, TISRH40LS, TISRH65SS, TISRH57SS, TISRH52SS, TISRH45SS)Transfer Impression Coping Set (Model: TISRN52SS, TISRN45SS, TISRN40SS, TISXN40LS, TISXN40SS, TISRH65LS, TISRH57LS)Transfer Impression Coping Set (Model: TISRN65LS, TISRN57LS, TISRN52LS, TISRN45LS, TISRN40LS, TISRN65SS, TISRN57SS)Transfer Impression Coping Set (Model: TITMH45SS, TITMH40SS)Transfer Impression Coping Set (Model: TITMN45SS, TITMN40SS, TITRH70LS, TITRH60LS, TITRH50LS, TITRH45LS, TITRH40LS)Transfer Impression Coping Set (Model: TITRH70SS, TITRH60SS, TITRH50SS, TITRH45SS, TITRH40SS, TITMH45LS, TITMH40LS)Transfer Impression Coping Set (Model: TITRN70SS, TITRN60SS, TITRN50SS, TITRN45SS, TITRN40SS, TITMN45LS, TITMN40LS)Unigrip Driver for Ratchet (Model: UNDR1710, UNDR1715, UNDR1725)Unigrip Lab Driver (Model: UNLD1725)ZENEX Anchor Guide Sleeve (Model: ZAGS30)ZENEX Bone Scraper (Model: ZBOSCSK, ZBOSCNK)ZENEX Direct Kit (Model: ZENDTSKIT, ZENDTTKIT, ZENDTRKIT)ZENEX EASY SURGERY KIT (Iran I-System) (Model: ZENIRESKIT)ZENEX EASY SURGERY KIT (Model: ZENESKIT, ZENESSKIT, ZENESTKIT, ZENESRKIT, ZENESATKIT)ZENEX Guide Anchor Pin (Model: ZGAP13S, ZGAP13L)ZENEX Guide Anchor Screw (Model: ZGAS16)ZENEX Guide Fixture Driver for Contra Angle (Model: ZGFDCSN21M, ZGFDCSM25M, ZGFDCTM21M, ZGFDCRM23M)ZENEX Guide Fixture Driver for Ratchet (Model: ZGFDRSN21M, ZGFDRSM25M, ZGFDRTM21M, ZGFDRRM23M)ZENEX Guide Hands on Kit (Model: ZENGUHKIT)ZENEX Guide Kit (Model: ZENGUKIT, ZENGUSKIT, ZENGUTKIT, ZENGURKIT)ZENEX Guide Mini Kit (Model: ZENGMKIT, ZENGMSKIT, ZENGMTKIT, ZENGMRKIT, ZENGMATKIT)ZENEX Guide Wide KIT (Model: ZENGWKIT, ZENGWSKIT, ZENGWRKIT)ZENEX Micro Bone Scraper (Model: ZMBSC)ZENEX PROSTHETIC KIT (Model: ZENPRKIT)ZENEX S KIT (Model: ZENSKIT, ZENSSKIT, ZENSTKIT, ZENSRKIT)ZENEX SIMPLE KIT (Model: ZENIRSPSKIT)ZENEX Simple Kit (Model: ZENSPATKIT)ZENEX Simple Kit (Model: ZENSPS3CKIT, ZENSPAT3CKIT, ZENSPR3CKIT)ZENEX SIMPLE KIT (Model: ZENSPSKIT, ZENSPTKIT, ZENSPRKIT, ZENSPATKIT, ZENSPS3CKIT, ZENSPAT3CKIT, ZENSPR3CKIT)ZENEX Slim KIT (Model: ZENSLKIT, ZENSLSKIT, ZENSLTKIT, ZENSLRKIT, ZENSL3CKIT, ZENSLS3CKIT, ZENSLT3CKIT, ZENSLR3CKIT)ZENEX SUPERWIDE KIT (Model: ZENSWKIT, ZENSWSKIT, ZENSWTKIT, ZENSWRKIT)ZENEX Surgery Hands on Kit (Model: ZENSGHKIT)ZENEX Surgery Kit (Model: ZENSG3CKIT, ZENSGS3CKIT, ZENSGAT3CKIT, ZENSGR3CKIT)ZENEX SURGERY KIT (Model: ZENSGKIT, ZENSGSKIT, ZENSGTKIT, ZENSGRKIT, ZENSGATKIT)ZENEX Surgical Guide Sleeve (Model: ZGS41M, ZGS53R, ZGS70W)ZENEX Taper Kit (Model: ZENTASKIT, ZENTATKIT, ZENTARKIT)ZENEX Tissue Scraper (Model: ZTISCTK15)1.2 Hex Angled Driver for Ratchet (Model: HEADR1215, HEADR1220, HEADR1225)1.2 Hex Driver for Ratchet (Model: HEDR1207)1.2 Hex Driver for Ratchet (Model: HEDR1210, HEDR1215, HEDR1225)1.2 Hex Lab Driver (Model: HEDR1207, HELD1225)1.2 Hex Machine Screw Driver (Model: HEDM1210, HEDM1215)1.25 Hex Driver for Ratchet (Model: HEDR12510, HEDR12515, HEDR12525) | 2021 |
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 Izenimplant Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Mar 2026 | K253334 | ZENEX Implant System_Short (R-System) | DZE Root-Form Endosseous Implant |
| 8 Jan 2026 | K252585 | ZENEX Implant System_R-System | DZE Root-Form Endosseous Implant |
| 30 Oct 2024 | K240560 | ZENEX Implant System_Long | DZE Root-Form Endosseous Implant |
| 12 Jan 2024 | K232170 | Ti Link Abutment | NHA Endosseous Dental Implant Abutment |
| 19 Dec 2023 | K233163 | ZENEX Implant System_Short | DZE Root-Form Endosseous Implant |
| 24 Aug 2023 | K231557 | ZENEX FreeMilling & CCM Cast Abutment | NHA Endosseous Dental Implant Abutment |
| 31 Jul 2023 | K230630 | ZENEX Implant System_Narrow | DZE Root-Form Endosseous Implant |
| 13 Apr 2022 | K211090 | ZENEX Implant System | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IZENIMPLANT CO., LTD.FDA reg. 3018097239 | Pyeongtaek-si Gyeonggi, South Korea | Manufacturer |
| IZENIMPLANT CO., LTD.FDA reg. 3031493119 | Hwaseong-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10080021). 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.