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
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-01-07 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2023-12-20 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2022-04-21 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2021-01-07 |
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