FDA Registration Active 🇰🇷 South Korea

IZENIMPLANT CO., LTD.

Reg #: 3018097239 · FEI: 3018097239 · Expires 2026
Products
4
Proprietary Names
172
Establishment Types
1
Classifications
4

Registration Details

Registration Name
IZENIMPLANT CO., LTD.
Registration Number
3018097239
FEI Number
3018097239
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon
City
Pyeongtaek-si Gyeonggi
Country
KR

Regulatory Submissions

510(k) Number
K233163

Owner / Operator

Firm Name
Izenimplant Co., Ltd.
Operator Number
10080021
Address
1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon
City
Pyeongtaek-si
State
Gyeonggi
Postal Code
17703
Country
KR

US Agent

Business Name
Withus Group Inc
Contact Name
April Lee
Address
106 Superior
City
Irvine
State
CA
ZIP
92620
Country
US
Phone
909 2749971

Products

Device Name Product Code
Accessories, Implant, Dental, Endosseous NDP
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA
Drill, Dental, Intraoral DZA

Proprietary Names

All in One Mount (Model: AOMRR23S, AOMRR23L) Unigrip Driver for Ratchet (Model: UNDR1710, UNDR1715, UNDR1725) Driver Shaft for Contra Angle Anchor Type (Model: DSCA20JTNP, DSCA20JTCP) Multi Pick-up Impression Coping (Model: MPICSR48, MTPICSR48) 1.2 Hex Angled Driver for Ratchet (Model: HEADR1215, HEADR1220, HEADR1225) ZENEX Guide Hands on Kit (Model: ZENGUHKIT) ZENEX Surgical Guide Sleeve (Model: ZGS41M, ZGS53R, ZGS70W) ZENEX SURGERY KIT (Model: ZENSGKIT, ZENSGSKIT, ZENSGTKIT, ZENSGRKIT, ZENSGATKIT) Multi Lab Analog (Model: MLASR48) Transfer Impression Coping (Model: TISRN52S, TISRN57S, TISRN65S, TISRN40L, TISRN45L, TISRN52L, TISRN57L, TISRN65L) Bite Impression Coping (Model: BICSR4043, BICSR4044, BICSR4045, BICSR4064, BICSR4065, BICSR4066, BICSR4542, BICSR4543) 1.2 Hex Driver for Ratchet (Model: HEDR1207) Abutment Remover (Model: ARRM18L) Bite Impression Coping (Model: BICTM4042, BICTM4043, BICTM4044, BICTM4064, BICTM4066, BICTM4542, BICTM4543, BICTM4544) Drill Extension (Model: DE4513) Abutment Remover (Model: ARRM18) 1.2 Hex Machine Screw Driver (Model: HEDM1210, HEDM1215) Transfer Impression Coping (Model: TITRN45L, TITRN50L, TITRN60L, TITRN70L, TIRRH40S, TIRRH40L, TIRRH50S, TIRRH50L) Slot Driver for Ratchet (Model: SLDR0510, SLDR0515, SLDR0525) Multi Pick-up Impression Coping Guide Pin (Model: MPICSRGP, MPICSRGPL, MTPICSRGP, MTPICSRGPL) Bone Profiler Guide Screw (Model: SBPGSSX14, SBPGSSN20, SBPGSSM20, SBPGSSR20, SBPGSTM20, SBPGSRM18, SBPGSRR18) Pick-up Impression Coping Guide Pin (Model: PIGPRRS, PIGPRRL) Reverse Scanbody (Model: MRSBSR48) ZENEX Slim KIT (Model: ZENSLKIT, ZENSLSKIT, ZENSLTKIT, ZENSLRKIT) Pick-up Impression Coping (Model: PISXH40S, PISXH40L, PISRH40S, PISRH45S, PISRH52S, PISRH57S, PISRH65S, PISRH40L) Transfer Impression Coping (Model: TITMN40L, TITMN45L, TITRN40S, TITRN45S, TITRN50S, TITRN60S, TITRN70S, TITRN40L) SCS Lab Driver (Model: SCLD1725) Multi Angled Abutment Carrier (Model: MAACRMC) Bite Impression Coping Guide Pin (Model: BIGPSR42, BIGPSR45, BIGPSR64, BIGPSR65, BIGPSR66, BIGPSX42, BIGPSX43, BIGPSX44) Bite Impression Coping (Model: BICRR6045, BICRR6064, BICRR6065, BICRR6066, BICRR7043, BICRR7044, BICRR7045, BICRR7064) Drill Stopper Holder (Model: TDDSH60) Bite Impression Coping (Model: BICRR7065, BICRR7066) Bite Impression Coping (Model: BICSR5245, BICSR5264, BICSR5265, BICSR5266, BICSR5743, BICSR5744, BICSR5745, BICSR5764) Torque Wrench (Model: TW60B) Driver Shaft for Contra Angle O-ring Type (Model: DSCA20JBN, DSCA20JTN, DSCA20WBN, DSCA20OBN, DSCA20SBN, DSCA40JBN) Pick-up Impression Coping (Model: PITRN45L, PITRN50L, PITRN60L, PITRN70L, PIRRH40S, PIRRH40L, PIRRH50S, PIRRH50L) Bite Impression Coping (Model: BICTR4545, BICTR4564, BICTR4565, BICTR4566, BICTR5042, BICTR5043, BICTR5044, BICTR5045) 1.2 Hex Lab Driver (Model: HEDR1207, HELD1225) Multi Plastic Cast Cylinder (Model: MPCCSRN48) Bite Impression Coping (Model: BICSR4544, BICSR4545, BICSR4564, BICSR4565, BICSR4566, BICSR5242, BICSR5243, BICSR5244) Pick-up Impression Coping (Model: PITMN40L, PITMN45L, PITRN40S, PITRN45S, PITRN50S, PITRN60S, PITRN70S, PITRN40L) Multi Healing Cap (Model: MHCSR48) ZENEX Taper Kit (Model: ZENTASKIT, ZENTATKIT, ZENTARKIT) Bite Impression Coping Guide Pin (Model: BIGPSX64, BIGPSX66, BIGPRR42, BIGPRR43, BIGPRR44, BIGPRR45, BIGPRR64, BIGPRR65) Unigrip Lab Driver (Model: UNLD1725) Transfer Impression Coping (Model: TIRRH60S, TIRRH60L, TIRRH70S, TIRRH70L, TIRRN40S, TIRRN40L, TIRRN50S, TIRRN50L) Transfer Impression Coping Guide Pin (Model: TIGPSXS, TIGPSXL, TIGPSRS, TIGPSRL, TIGPTMS, TIGPTML, TIGPTRS, TIGPTRL) Fixture Lab Analog (Model: FLASX300, FLASN300, FLASM350, FLASR400) Driver Shaft for Contra Angle O-ring Type (Model: DSCA40JTN, DSCA40WBN, DSCA40OBN, DSCA40SBN) Steel Bowl (Model: STBOWL) ZENEX Guide Kit (Model: ZENGUKIT, ZENGUSKIT, ZENGUTKIT, ZENGURKIT) Pick-up Impression Coping (Model: PITMH40S, PITMH45S, PITMH40L, PITMH45L, PITRH40S, PITRH45S, PITRH50S, PITRH60S) Transfer Impression Coping (Model: TITMH40S, TITMH45S, TITMH40L, TITMH45L, TITRH40S, TITRH45S, TITRH50S, TITRH60S) ZENEX Simple Kit (Model: ZENSPS3CKIT, ZENSPAT3CKIT, ZENSPR3CKIT) All in One Mount (Model: AOMSX17S, AOMSX17L, AOMSR25S, AOMSR25L, AOMTM21S, AOMTM21L, AOMTR25S, AOMTR25L) 1.25 Hex Driver for Ratchet (Model: HEDR12510, HEDR12515, HEDR12525) Bite Impression Coping (Model: BICTR5064, BICTR5065, BICTR5066, BICTR6043, BICTR6044, BICTR6045, BICTR6064, BICTR6065) Ball Abutment Lab O-ring (Model: BASRLO) Pick-up Impression Coping Guide Pin (Model: PIGPSXS, PIGPSXL, PIGPSRS, PIGPSRL, PIGPTMS, PIGPTML, PIGPTRS, PIGPTRL) SCS Driver for Ratchet (Model: SCDR1710, SCDR1715, SCDR1725) Finger Driver for Driver Shaft (Model: FDDS100) Multi Transfer Impression Coping (Model: MTICSR48) Pick-up Impression Coping (Model: PITRH70S, PITRH40L, PITRH45L, PITRH50L, PITRH60L, PITRH70L, PITMN40S, PITMN45S) Shank Driver (Model: SD70) Direction Pin (Model: DPSX3510, DPSN3510, DPSM3510, DPSR4509, DPTM4010, DPRR4009) Pick-up Impression Coping (Model:PISRN52S, PISRN57S, PISRN65S, PISRN40L, PISRN45L, PISRN52L, PISRN57L, PISRN65L) ZENEX Surgery Hands on Kit (Model: ZENSGHKIT) ZENEX S KIT (Model: ZENSKIT, ZENSSKIT, ZENSTKIT, ZENSRKIT) ZENEX Guide Wide KIT (Model: ZENGWKIT, ZENGWSKIT, ZENGWRKIT) ScanBody Screw (Model: ISBSM4014, ISBSR4310, TSBSM4014, TSBSR4310, RSBSR4310) ZENEX Direct Kit (Model: ZENDTSKIT, ZENDTTKIT, ZENDTRKIT) 1.2 Hex Driver for Ratchet (Model: HEDR1210, HEDR1215, HEDR1225) ZENEX SIMPLE KIT (Model: ZENSPSKIT, ZENSPTKIT, ZENSPRKIT, ZENSPATKIT, ZENSPS3CKIT, ZENSPAT3CKIT, ZENSPR3CKIT) Multi Straight Abutment Driver (Model: MSADSR20, MSADSC20) Transfer Impression Coping (Model: TITRH70S, TITRH40L, TITRH45L, TITRH50L, TITRH60L, TITRH70L, TITMN40S, TITMN45S) ZENEX Guide Anchor Screw (Model: ZGAS16) Pick-up Impression Coping (Model: PIRRH60S, PIRRH60L, PIRRH70S, PIRRH70L, PIRRN40S, PIRRN40L, PIRRN50S, PIRRN50L) Mount Driver (Model: MDCAS, MDRAS) ZENEX Guide Fixture Driver for Ratchet (Model: ZGFDRSN21M, ZGFDRSM25M, ZGFDRTM21M, ZGFDRRM23M) Bite Impression Coping (Model: BICTR6066, BICTR7043, BICTR7044, BICTR7045, BICTR7064, BICTR7065, BICTR7066, BICSX4042) Ball Abutment Lab Analog (Model: BAALA) Screw Driver Holder (Model: TSDH150) Bite Impression Coping (Model: BICSR5765, BICSR5766, BICSR6543, BICSR6544, BICSR6545, BICSR6564, BICSR6565, BICSR6566) Fixture Driver for Contra Angle (Model: FDCSX17L, FDCSR25S, FDCSR25L, FDCTM21S, FDCTM21L, FDCTR25S, FDCTR25L, FDCRR23S) Pick-up Impression Coping (Model: PIRRN60S, PIRRN60L, PIRRN70S, PIRRN70L) Bite Impression Coping Guide Pin (Model: BIGPRR66, BIGPSR43, BIGPSR44, BIGPTM42, BIGPTM43, BIGPTM44, BIGPTM64, BIGPTM66) ZENEX Guide Fixture Driver for Contra Angle (Model: ZGFDCSN21M, ZGFDCSM25M, ZGFDCTM21M, ZGFDCRM23M) Transfer Impression Coping (Model: TISRH45L, TISRH52L, TISRH57L, TISRH65L, TISXN40S, TISXN40L, TISRN40S, TISRN45S) ScanBody (Model: IRSBR4310, IISBM4214, IISBR4410, ITSBM4114, ITSBR4510) Multi Straight Abutment Carrier (Model: MSACR48) Fixture Driver for Contra Angle (Model: FDCRR23L) Pick-up Impression Coping (Model: PISRH45L, PISRH52L, PISRH57L, PISRH65L, PISXN40S, PISXN40L, PISRN40S, PISRN45S) ZENEX Anchor Guide Sleeve (Model: ZAGS30) ZENEX Simple Kit (Model: ZENSPATKIT) Screw Driver Connector (Model: TSDH80C) ZENEX EASY SURGERY KIT (Model: ZENESKIT, ZENESSKIT, ZENESTKIT, ZENESRKIT, ZENESATKIT) Bite Impression Coping (Model: BICRR5043, BICRR5044, BICRR5045, BICRR5064, BICRR5065, BICRR5066, BICRR6043, BICRR6044) ZENEX Surgery Kit (Model: ZENSG3CKIT, ZENSGS3CKIT, ZENSGAT3CKIT, ZENSGR3CKIT) Multi ScanBody Screw (Model: MSBSRS14) Prosthetic Driver Full KIT (Model: PDFK) Multi ScanBody (Model: MSBSR4809) Parallel Pin (Model: PP351822, PP501822) ZENEX PROSTHETIC KIT (Model: ZENPRKIT) Transfer Impression Coping (Model: TISXH40S, TISXH40L, TISRH40S, TISRH45S, TISRH52S, TISRH57S, TISRH65S, TISRH40L) Transfer Impression Coping (Model: TIRRN60S, TIRRN60L, TIRRN70S, TIRRN70L) Fixture Driver for Ratchet (Model: FDRSX1720, FDRSR2520, FDRTM2120, FDRTR2520, FDRRR2320) ZENEX Guide Mini Kit (Model: ZENGMKIT, ZENGMSKIT, ZENGMTKIT, ZENGMRKIT, ZENGMATKIT) Ball Abutment Driver (Model: BAD24) Prosthetic Driver KIT (Model: PDK) Depth Gauge (Model: DG1720) Drill Stopper (Model: TDDS03B, TDDS04P, TDDS05Y, TDDS06G, TDDS07B, TDDS08P, TDDS10Y, TDDS11G, TDDS13B, TDDS15P) Bite Impression Coping Guide Pin (Model: BIGPTR42, BIGPTR43, BIGPTR44, BIGPTR45, BIGPTR64, BIGPTR65, BIGPTR66) ZENEX SUPERWIDE KIT (Model: ZENSWKIT, ZENSWSKIT, ZENSWTKIT, ZENSWRKIT) Ball Abutment O-ring (Model: BASRR) Transfer Impression Coping Guide Pin (Model: TIGPRRS, TIGPRRL) ZENEX Implant System_Short ZENEX Implant System ZENEX Implant System_R-System ZENEX Implant System_Short (R-System) ZENEX Implant System_Narrow ZENEX Implant System_Long Taper Drill (Model Name: TAD3F5515) Point drill (Model: PDN3F20S, PDN3F20L) Twist Drill (Model: TD3F46S, TD3F30L, TD3F36L, TD3F41L, TD3F46L) Dental T-Shaper (Model: DTSD18) ZENEX Guide Initial Drill (Model: ZGID2204R, ZGID2207R, ZGID2208R, ZGID2210R, ZGID2211R, ZGID2213R, ZGID2205M) Cortical Drill (Model: CD3FXF30, CD3FNF30, CD4FF35, CD4FF40, CD4FF45, CD4FF50, CD4FF55, CD4FF60, CD4FF70) Lindemann Drill (Model: LD4F25L, LD4F20S, LD4F20L, LD4F25S, LD4F35M) ZENEX Guide Twist Drill (Model: ZGTD3013M, ZGTD3015M, ZGTD3005R, ZGTD3007R, ZGTD3008R, ZGTD3010R, ZGTD3011R, ZGTD3013R) ZENEX Guide Start Drill (Model: ZGSD30R, ZGSD36R, ZGSD41R, ZGSD46R) Taper Drill (Model: TAD3F3506, TAD3F3507, TAD3F3508, TAD3F3510, TAD3F3511, TAD3F3513, TAD3F3515, TAD3F4006, TAD3F4007) Taper Cortical Drill (Model: TACD4FF55, TACD4FF35, TACD4FF40, TACD4FF45, TACD4FF50) ZENEX Guide Flattening Drill (Model: ZGFD3712M, ZGFD4609R, ZGFD4610R, ZGFD4612R, ZGFD5209W, ZGFD3512M, ZGFD4709R) ZENEX Guide Twist Drill (Model: ZGTD6510W, ZGTD6511W, ZGTD3018R, ZGTD3020R, ZGTD3618R, ZGTD3620R, ZGTD4118R, ZGTD4120R) Step Drill (Model: TD3F5213, TD3F5215, TD3F5506, TD3F5507, TD3F5508, TD3F5510, TD3F5511, TD3F5513, TD3F5515, TD3F6213) ZENEX Guide Twist Drill (Model: ZGTD3018R, ZGTD3020R, ZGTD3618R, ZGTD3620R, ZGTD4118R, ZGTD4120R) BT Profiler for Healing Abutment (Model: BTP50M, BTP50R) ZENEX Guide Twist Drill (Model: ZGTD4607R, ZGTD4608R, ZGTD4610R, ZGTD4611R, ZGTD4613R, ZGTD4615R, ZGTD4605W, ZGTD4606W) Twist Drill (Model: TD2F46L, TD2F25S, TD2F27S, TDM2F22L, TDM2F25L, TDM2F27L, TDM2F30L, TD3F30S, TD3F36S, TD3F41S) ZENEX Guide Anchor Drill (Model: ZGAD13) Twist Drill (Model: TD2F22S, TD2F22L, TD2F25L, TD2F27L, TD2F30S, TD2F30L, TD2F36S, TD2F36L, TD2F41S, TD2F41L, TD2F46S) Taper Drill (Model Name: TAD3F5013, TAD3F5015, TAD3F5506, TAD3F5507, TAD3F5508, TAD3F5510, TAD3F5511, TAD3F5513) Step Drill (Model: TD2F4107, TD2F4108, TD2F4110, TD2F4111, TD2F4113, TD2F4115, TD2F4118, TD2F4120, TD2F4606, TD2F4607) Step Drill (Model: TD2F3606, TD2F3607, TD2F3608, TD2F3610, TD2F3611, TD2F3613, TD2F3615, TD2F3618, TD2F3620, TD2F4106) Drill for Orthodontic (Model: D10OTC, D13OTC, D15OTC) ZENEX Guide Cortical Drill (Model: ZGCDF35R, ZGCDF40R, ZGCDF45R, ZGCDF50R) ZENEX Guide Initial Drill (Model: ZGID2218R, ZGID2220R) ZENEX Guide Twist Drill (Model: ZGTD5507W, ZGTD5508W, ZGTD5510W, ZGTD5511W, ZGTD6505W, ZGTD6506W, ZGTD6507W, ZGTD6508W) Step Drill (Model: TD2F2206, TD2F2207, TD2F2208, TD2F2210, TD2F2211, TD2F2213, TD2F2215, TD2F2506, TD2F2507, TD2F2508) ZENEX Guide Tissue Punch (Model: ZGTP3808R, ZGTP4308R, ZGTP4808R, ZGTP5308R, ZGTP3808M, ZGTP6007W) ZENEX Guide Twist Drill (Model: ZGTD4607W, ZGTD4608W, ZGTD4610W, ZGTD4611W) Taper Drill (Model Name: TAD3F4511, TAD3F4513, TAD3F4515, TAD3F5006, TAD3F5007, TAD3F5008, TAD3F5010, TAD3F5011) ZENEX Guide Twist Drill (Model: ZGTD3015R, ZGTD3605R, ZGTD3607R, ZGTD3608R, ZGTD3610R, ZGTD3611R, ZGTD3613R, ZGTD3615R) 1.2 Hex Angled Machine Screw Driver (Model: HEADM1215, HEADM1220) Twist Drill (Non-stopper) (Model: TDN3F46S, TDN3F46L, TDN3F41S, TDN3F41L, TDN3F36S, TDN3F36L, TDN3F30S, TDN3F30L) Step Drill (Model: TD2F4608, TD2F4610, TD2F4611, TD2F4613, TD2F4615, TD3F5206, TD3F5207, TD3F5208, TD3F5210, TD3F5211) ZENEX Guide Twist Drill (Model: ZGTD2708M, ZGTD2710M, ZGTD2711M, ZGTD2713M, ZGTD2715M, ZGTD3008M, ZGTD3010M, ZGTD3011M) Bone Profiler (Model: SBP41, SBP46, SBP56, SBP76) Guide Drill (Model: GD3F20L, GD3F20S, GD3F25S, GD3F25L, GDN3F20S, GDN3F20L) Trephine Drill (Model: TD4218, TD5218, TD3718, TD4718, TD5718, TD6218) Taper Drill (Model: TAD3F4008, TAD3F4010, TAD3F4011, TAD3F4013, TAD3F4015, TAD3F4506, TAD3F4507, TAD3F4508, TAD3F4510) Guide Drill (Non-stopper) (Model: GDN3F20S, GDN3F20L) Tissue Punch (Model: TP3308, TP3808, TP4308, TP4808, TP5308) Twist Drill (Model: TD3F30S, TD3F30L, TD3F36S, TD3F36L, TD3F41S, TD3F41L, TD3F46S, TD3F46L) Step Drill (Model: TD3F6506, TD3F6507, TD3F6508, TD3F6510, TD3F6511, TD3F6513) ZENEX Guide Twist Drill (Model: ZGTD4105R, ZGTD4107R, ZGTD4108R, ZGTD4110R, ZGTD4111R, ZGTD4113R, ZGTD4115R, ZGTD4605R) ZENEX Guide Flattening Drill (Model: ZGFD4710R, ZGFD4712R, ZGFD6309W) Short Step Drill (Model: SSD2F22, SPD4F40) ZENEX Guide Twist Drill (Model: ZGTD3005W, ZGTD3006W, ZGTD3007W, ZGTD3008W, ZGTD3010W, ZGTD3011W, ZGTD5505W, ZGTD5506W) Short Drill (Model: SD4F45, SD4F49, SD4F53, SD4F57, SD4F66) ZENEX FreeMilling & CCM Cast Abutment Ti Link Abutment

Establishment Types

Manufacture Medical Device