IZENIMPLANT CO., LTD.

FDA Device Registration & Listing · Hwaseong-si Gyeonggi, KR · Registration 3031493119

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031493119
FEI Number
3031493119
Entity Name
IZENIMPLANT CO., LTD.
City/State/Country
Hwaseong-si Gyeonggi, KR
Establishment Address
30, Jeongnamsandan 1-gil, Jeongnam-myeon, Hwaseong-si Gyeonggi 18514, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Izenimplant Co., Ltd. (Owner Number: 10080021)
Owner / Operator Contact Address
1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, KR-41 17703, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Ti Link Abutment ZENEX Implant System_Long ZENEX FreeMilling & CCM Cast Abutment 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 Implant System_Short 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_Narrow

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-01-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-11-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-25
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2021-01-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-12-20
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2021-01-07
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-08-01

Official Correspondent

No official correspondent registered.

US Agent Details

April Lee Business: Withus Group Inc. Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

Izenimplant Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018097239 IZENIMPLANT CO., LTD. Pyeongtaek-si Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21
K130140 Intra-Lock International INTRA-LOCK OP DENTAL IMPLANT 2013-08-01
K925778 Nobelpharma USA, Inc. BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES 1993-04-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026 S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil 2
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 2
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031493119. Last updated year: 2026. Please use registration number 3031493119 when referencing this establishment in official correspondence.
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