IZENIMPLANT CO., LTD.

FDA Device Registration & Listing · Pyeongtaek-si Gyeonggi, KR · Registration 3018097239

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
3018097239
FEI Number
3018097239
Entity Name
IZENIMPLANT CO., LTD.
City/State/Country
Pyeongtaek-si Gyeonggi, KR
Establishment Address
1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si Gyeonggi 17703, 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

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2021-01-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-12-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-04-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-04-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-01-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2026-01-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2026-03-17
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
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-11-06
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2021-01-07
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-25

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
3031493119 IZENIMPLANT CO., LTD. Hwaseong-si Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K903999 O Co., Inc. OBUTMENT HB 1992-02-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018097239. Last updated year: 2026. Please use registration number 3018097239 when referencing this establishment in official correspondence.
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