CORTEX DENTAL IMPLANTS INDUSTRIES LTD.

FDA Device Registration & Listing · Shlomi Northern, IL · Registration 3007842672

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
3007842672
FEI Number
3007842672
Entity Name
CORTEX DENTAL IMPLANTS INDUSTRIES LTD.
City/State/Country
Shlomi Northern, IL
Establishment Address
Yaara Street 26, P.O. Box 125, Old Industrial area, Shlomi Northern 2283202, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Cortex Dental Implants Industries Ltd. (Owner Number: 10030174)
Owner / Operator Contact Address
Yaara Street 26, P.O. Box 125,, Shlomi Industrial zone, Shlomi, IL-NOTA 2283202, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PST-0838 PST-0842 PST-1038 PST-1042 PST-1138 PST-1142 PST-1338 PST-1342 PST-1638 PST-1642 CT-S107 CT-S110 CT-S115 CT-S207 CT-S210 CT-S215 CT-0220 CT-0230 CT-0231 CT-0232 CT-H210 CT-H215 CT-H220 CT-D210 CT-D215 CT-D220 CK-0009 CK-0010 CK-0060 CK-0061 CT-0242 CT-0250 CT-0252 CT-0254 CT-0260 CT-0262 CT-S262 CT-0410 CT-0413 CT-0500 CK-0062 CT-S218 CK-0042 CT-MUP00 CT-MUP09 CT-MUP18 CT-MUP30 CK-0011 CK-0011-T CK-0015 CK-0015-T CK-0022 CK-0022-T CT-0510 CT-0510C CT-0580 CT-0710 CT-0801 CT-0861 CT-0862 CT-0863 CT-0900 CT-H210 CT-MU01 CT-MU00 CT-MU02 Cortex CAD/CAM Abutments CD-GS1141 CD-GS1322 CD-GS1328 CD-GS1334 CD-GS1337 CD-GS1341 CD-GS1622 CD-GS1628 CD-GS1634 CD-GS1637 CD-1001 CD-5003 CD-5010 CD-5020 CD-5025 CD-5030 CD-5040 CD-5045 CD-5050 CD-5060 CD-GS1001 CD-GS1022 CD-GS1028 CD-GS1034 CD-GS1037 CD-GS1041 CD-GS1122 CD-GS1128 CD-GS1134 CD-GS1137 CD-4306 CD-4308 CD-4310 CD-4311 CD-4313 CD-GS0822 CD-GS0828 CD-GS0834 CD-GS0837 CD-GS0841 CO-GSMN CO-GSPS CO-GSS200 CO-GSSL3 CO-GSSL CT-FPDA CT-GS262 CT-GS400 CT-GS440 CT-GSFP CT-GSL262 CD-0210 CD-0211 CD-0213 CD-0216 CD-2806 CD-2808 CD-2810 CD-2811 CD-2813 CD-2816 CT-GSS440 CT-GSSPRING DO-ABUTP DO-ABUTT DO-ABUTZ DO-BRIDGEP DO-BRIDGEZ DO-CROWNP DO-CROWNZ DO-CUTBRZ CD-6030 CD-6040 CD-6050 CD-6060 CD-C038 CD-C042 CD-C050 CD-C060 CD-S1003 CD-S5003 MPR-GS5090 CO-GSFPSL CD-0206 CD-5065 CD-5110 CD-5120 CD-5140 CD-5148 CD-5137 CD-6003 CD-6010 CD-6020 CD-6025 MPR-GSS200 CD-GS1641 CD-GSFP CD-GSST52 CD-GSTCC CD-GSTCH CD-GSTFL CD-GSTP CD-S5010 CD-S5020 CD-S5025 CD-S5030 CD-S5040 CD-S5045 CD-S5050 CD-S5055 CD-S5060 CD-S5065 CK-GS11 CO-8040D CD-3206 CD-3208 CD-3210 CD-3211 CD-3213 CD-3706 CD-3708 CD-3710 CD-3711 CD-3713 MPR-GSCL CO-GS5090 MU-8041D MPN-GS5090 MPN-GSPS MPR-GS7000 MPN-GSCL CD-0208 MPN-GS7000 MPR-8040D CO-GSCL CK-GSPS MPN-GSS200 CO-GS7000 CO-S030 CO-S040 CO-S060 CO-S061 CO-S062 CO-S070 CS-0010 CS-8060 CS-8065 BCO-MU218 BCO-MU318 BCO-MU418 BCO-MU518 BCO-MU230 BCO-MU330 BCO-MU430 BCO-MU530 PCO-MU209 PCO-MU309 PCO-MU409 PCO-MU509 PCO-MU218 PCO-MU318 PCO-MU418 PCO-MU518 PCO-MU230 PCO-MU330 PCO-MU430 PCO-MU530 BCO-MUS1 BCO-MUS2 BCO-MUS3 BCO-MUS4 BCO-MUS5 BCO-MUS6 PCO-MU209 PCO-MU218 PCO-MU230 PCO-MU309 CO-AA151 CO-AA152 CO-AA153 CO-AA251 CO-AA252 CO-AA253 CO-PA001 CO-PA002 CO-PA003 CO-PA151 PCSD-1150 PCSD-1160 PCSD-1333 PCSD-1338 PCSD-1342 PCSD-1350 PCSD-1360 PCSD-1633 PCSD-1638 PCSD-1642 PCO-CCS1 PCO-CCS2 PCO-CCS3 PCO-CCS4 PCO-CCS5 CO-CCA20 CO-CCA30 CO-CCA40 CO-CCA50 CO-CCACA BCO-CC530 PCO-CC209 PCO-CC309 PCO-CC409 PCO-CC509 PCO-CC218 PCO-CC318 PCO-CC418 PCO-CC518 PCO-CC230 BCSC-1350 BCSC-1360 BCSC-1633 BCSC-1638 BCSC-1642 PCSC-0642 PCSC-0650 PCSC-0660 PCSC-0838 PCSC-0842 CO-PA151 CO-PA153 CO-PA251 CO-PA252 CO-PA253 CO-MUC20 CO-MUC30 CO-MUC40 CO-MUC50 CO-MUCPL PCSC-0850 PCSC-0860 PCSC-1033 PCSC-1038 PCSC-1042 PCSC-1050 PCSC-1060 PCSC-1133 PCSC-1138 PCSC-1142 CO-9315 CO-9325 CO-9415 CO-9425 CO-9700 C0-9701 CO-9705 CO-9710 CO-9711 CO-8900 CP-1030 CP-1033 CP-1130 CP-1133 CP-1330 CP-1333 CP-1630 CP-1633 BCO-MU209 BCO-MU218 PCSC-1150 PCSC-1160 PCSC-1333 PCSC-1338 PCSC-1342 PCSC-1350 PCSC-1360 PCSC-1633 PCSC-1638 PCSC-1642 CO-CCAS0 CO-CCAS1 CO-CCAS2 CO-CCAS3 CO-CCAS4 CO-CCAS5 CO-6201 CO-6202 CO-6203 CO-6204 CO-8901 CO-8902 CO-8903 CO-8910 CO-8911 CO-8912 CO-8913 CO-AA001 CO-AA002 CO-AA003 PCO-0218 PCO-0318 PCO-0418 PCO-0518 PCO-0230 PCO-0330 PCO-0430 PCO-0530 PCO-6201 PCO-6202 BST-0838 BST-0842 BST-1038 BST-1042 BST-1138 BST-1142 BST-1338 BST-1342 BST-1638 BST-1642 BCSD-1050 BCSD-1060 BCSD-1133 BCSD-1138 BCSD-1142 BCSD-1150 BCSD-1160 BCSD-1333 BCSD-1338 BCSD-1342 CM-0031 PCO-MU318 PCO-MU330 PCO-MU409 PCO-MU418 PCO-MU430 PCO-MU509 PCO-MU518 PCO-MU530 PCO-MUS1 PCO-MUS2 BCSD-0642 BCSD-0650 BCSD-0660 BCSD-0838 BCSD-0842 BCSD-0850 BCSD-0860 BCSD-1033 BCSD-1038 BCSD-1042 CO-8065 CO-8070 CO-8075 CO-8080 CO-8085 CO-CCADP CO-CCAIH CO-CCASR CO-CCATR CO-CCT28 CO-TBR4C CD-1001 CD-5003 CD-5010 CD-5020 CO-6021 CO-6022 CO-6030 CO-6020 PCO-CC330 PCO-CC430 PCO-CC530 BCO-CCS0 BCO-CCS1 BCO-CCS2 BCO-CCS3 BCO-CCS4 BCO-CCS5 PCO-CCS0 BCO-CC309 BCO-CC409 BCO-CC509 BCO-CC218 BCO-CC318 BCO-CC418 BCO-CC518 BCO-CC230 BCO-CC330 BCO-CC430 BCO-MU230 BCO-MU309 BCO-MU318 BCO-MU330 BCO-MU409 BCO-MU418 BCO-MU430 BCO-MU509 BCO-MU518 BCO-MU530 PCO-MUS3 PCO-MUS4 PCO-MUS5 PCO-MUS6 CO-5000 CO-5010 CO-5020 CO-5030 CO-6105 CO-6115 CO-8130 CO-8200 CO-9001 CO-9002 CO-9003 CO-9004 CO-9115 CO-9125 CO-9215 CO-9225 BCO-MUS1 BCO-MUS2 BCO-MUS3 BCO-MUS4 BCO-MUS5 BCO-MUS6 PCO-MUS1 PCO-MUS2 PCO-MUS3 PCO-MUS4 CO-8033 CO-8036 CO-8037 CO-8100 CO-8111 CO-8112 CO-8113 CO-8114 CO-8115 CO-8125 BCSD-1350 BCSD-1360 BCSD-1633 BCSD-1638 BCSD-1642 PCSD-0642 PCSD-0650 PCSD-0660 PCSD-0838 PCSD-0842 CO-MUS20 CO-MUS65 CO-MUSCA CO-MUA09 CO-MUA18 CO-MUA30 BCO-MU209 BCO-MU309 BCO-MU409 BCO-MU509 PCSD-0850 PCSD-0860 PCSD-1033 PCSD-1038 PCSD-1042 PCSD-1050 PCSD-1060 PCSD-1133 PCSD-1138 PCSD-1142 CO-7505 CO-7506 CO-8102 CO-8103 CO-8104 CO-8105 CO-8106 CO-8107 CO-MUCHC BCO-CC209 BCSC-0642 BCSC-0650 BCSC-0660 BCSC-0838 BCSC-0842 BCSC-0850 BCSC-0860 BCSC-1033 BCSC-1038 BCSC-1042 CO-9002C CO-8100C CO-9711C PCO-MUS5 PCO-MUS6 CO-7102 CO-7103 CO-7104 CO-7105 CO-7106 CO-7107 CO-7503 CO-7504 BCSC-1050 BCSC-1060 BCSC-1133 BCSC-1138 BCSC-1142 BCSC-1150 BCSC-1160 BCSC-1333 BCSC-1338 BCSC-1342 PCO-6203 PCO-6204 PCO-6205 PCO-6206 CO-8040 CO-8047 CO-8049 CO-8050 CO-8055 CO-8060 CO-AA003C CO-AA252C CO-TBH2C CO-6205 CO-6206 CO-B2380 CO-B3380 CO-B4380 CO-B5380 PCO-0209 PCO-0309 PCO-0409 PCO-0509 PST-0838 PST-0842 PST-1038 PST-1042 PST-1138 PST-1142 PST-1338 PST-1342 PST-1638 PST-1642 CO-7104C CO-AA251C CO-TBH1C CO-6125 CO-6605 CO-6606 CO-8000 CO-8015 CO-8025 CO-8029 CO-8030 CO-8031 CO-8032 CO-7106C CO-8028 CO-9125C CO-9001C CO-7103C CO-9004C CO-0620 CO-AA002C CO-9225C CO-TBH4C CO-9215C CO-TBH3C CO-AA151C CO-0621 CM-0041 CO-AA152C CO-PA003C CO-AA253C CO-AA153C CO-TBR3C CO-7107C CO-9315C CO-TBR1C CO-9325C CO-TBR2C CO-8065C CO-9415C CO-0630 CO-AA001C CO-0622 CO-9115C CO-7102C CO-9003C CO-8060C CO-8000C CO-8085C CO-9701C CO-8080C CO-9425C CO-7105C CORSCAN Digital Intraoral Scanner system

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 2014-12-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2014-12-08
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2011-07-12
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-12-21
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2011-06-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-08-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-08-23
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2025-12-14

Official Correspondent

Ran Amos

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Cortex Dental Implants Industries Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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 3007842672. Last updated year: 2026. Please use registration number 3007842672 when referencing this establishment in official correspondence.
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