FDA Registration
Active
🇮🇱 Israel
CORTEX DENTAL IMPLANTS INDUSTRIES LTD.
Reg #: 3007842672
·
FEI: 3007842672
·
Expires 2026
Products
5
Proprietary Names
205
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CORTEX DENTAL IMPLANTS INDUSTRIES LTD.
- Registration Number
- 3007842672
- FEI Number
- 3007842672
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Yaara Street 26, P.O. Box 125, Old Industrial area
- City
- Shlomi Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K131258
Owner / Operator
- Firm Name
- Cortex Dental Implants Industries Ltd.
- Operator Number
- 10030174
- Address
- Yaara Street 26, P.O. Box 125,, Shlomi Industrial zone
- City
- Shlomi
- State
- IL-NOTA
- Postal Code
- 2283202
- Country
- IL
- Correspondent
- Ran Amos
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2014-12-08 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2014-12-08 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-07-12 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2011-06-18 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2025-12-14 |
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
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
MPW-9315 MPW-9325 MPW-9415 MPW-9425 MPW-9700 MPW-9701 MPW-9710 MPW-9711 MPW-S030 MPW-S060
PMCD-1360 PMCD-1630 PMCD-1633 PMCD-1642 MPN-6105 MPN-6115 MPN-6125 MPN-8000 MPN-8036
PMCC-1342 PMCC-1350 PMCC-1360 PMCC-1633 PMCC-1638 PMCC-1642 PMCD-0642 PMCD-0650 PMCD-0660 PMCD-0838
BMCC-0650 BMCC-0660 BMCC-0838 BMCC-0842 BMCC-0850 BMCC-0860 BMCC-1033 BMCC-1038 BMCC-1042 BMCC-1050
MPW-8040 MPW-8060 MPW-8080
BMCD-1150 BMCD-1160 BMCD-1330 BMCD-1333 BMCD-1338 BMCD-1342 BMCD-1350 BMCD-1630 BMCD-1633 BMCD-1638 BMCC-0642
MPW-7503 MPW-7504 MPW-7505 MPW-7506 MPW-7605 MPW-7607 MPR-S070 MPR-S080 MPR-S085 MPW-S060 MPW-S080 MPR-S010
MCT-N207 MCT-N210 MCT-N215 MCT-N220 MCT-R207 MCT-R210 MCT-R215 MCT-R220 MCT-W207 MCT-W210 MCT-W215 MCT-W220
MPN-5130 MPN-5230 MPN-5330 MPN-5145 MPN-5245 MPN-5345 MPW-5100 MPW-5200 MPW-5300 MPW-5118
MPW-8115 MPW-8125 MPW-9001 MPW-9002 MPW-9003 MPW-9004 MPW-9115 MPW-9125 MPW-9215 MPW-9225
PMCD-1133 PMCD-1138 PMCD-1142 PMCD-1150 PMCD-1160 PMCD-1330 PMCD-1333 PMCD-1338 PMCD-1342 PMCD-1350
MPN-6203 MPN-6204 MPN-6205 MPR-6201 MPR-6202 MPR-6203 MPR-6204 MPR-6205 MPR-6206 MPR-6207
MPR-PA15 MPR-PA25 MPW-6105 MPW-6115 MPW-6125 MPW-8000 MPW-8036
BCDL-1133 BCDL-1138 BCDL-1142 BCDL-1333 BCDL-1338 BCDL-1342 BCDL-1633 BCDL-1638 BCDL-1642
MPR-9700 MPR-9701 MPR-9710 MPR-9711 MPR-S010 MPR-S030 MPR-S040 MPR-S060 MPR-S080 MPR-S085 MPR-PA00
BCDL-0833 BCDL-0838 BCDL-0842 BCDL-1033 BCDL-1038 BCDL-1042 MPN-S010 MPW-S010 MPR-0055 MPR-0070 MPW-S006A
CO-5518
MPN-8104 MPN-8105 MPN-8106 MPN-8107 MPR-7102 MPR-7103 MPR-7104 MPR-7105 MPR-7106 MPR-7107
BMCD-1030 BMCD-1033 BMCD-1038 BMCD-1042 BMCD-1050 BMCD-1060 BMCD-1130 BMCD-1133 BMCD-1138 BMCD-1142
MPR-9003 MPR-9004 MPR-9115 MPR-9125 MPR-9215 MPR-9225 MPR-9315 MPR-9325 MPR-9415 MPR-9425
MPW-SSB MPW-TBCRC MPW-TBCRCR MPW-TBH1 MPW-TBH2 MPW-TBH3 MPW-TBH4 MPW-TBR1 MPW-TBR2 MPW-TBR3
MPN-8115 MPN-8125 MPN-9001 MPN-9002 MPN-9003 MPN-9004 MPN-9115 MPN-9125
MPN-TBH3 MPN-TBR1 MPN-TBR2 MPN-TBR3 MPR-TBCRC MPR-TBCRCR MPR-TBH1 MPR-SBZZ MPR-SPCRC MPR-SSB
MPN-9215 MPN-9225 MPN-9315 MPN-9325 MPN-9415 MPN-9425 MPN-9700 MPN-9701 MPN-9710 MPN-9711
MPN-8040 CO-SBMU MPW-8040D MPW-SBZZ MPW-SPCRC
CO-TBR3 CO-TBR4 MPN-TBCRC MPN-TBCRCR MPN-TBH1 MPN-TBH2 MPW-TBR4 MU-LTSST MU-STSST MU-S010 MU-SSB
CO-5200
CO-SBZZ CO-SPCRC CO-TBCRC CO-TBCRCR CO-TBH1 CO-TBH2 CO-TBH3 CO-TBH4 CO-TBR1 CO-TBR2
MU-5080 MU-S060 MU-S080 MU-8041 MU-50PL MU-50TS MU-50TL MU-50SPL MPN-8102 MPN-8103
CO-5300
MPR-SB13I
MPW-6201 MPW-6202 MPW-6203 MPW-6204 MPW-6205 MPW-6206 MPW-8040 MU-S020 MU-50HC MU-5060
MPN-SB05I
MPR-8000 MPR-8036 MPR-8040 MPR-8060 MPR-8080 MPR-8085 MPR-8115 MPR-8125 MPR-9001 MPR-9002
MPW-SB13I
CO-SB09I
PMCD-0842 PMCD-0850 PMCD-0860 PMCD-1030 PMCD-1033 PMCD-1038 PMCD-1042 PMCD-1050 PMCD-1060 PMCD-1130
CO-5230
PMCC-1042 PMCC-1050 PMCC-1060 PMCC-1133 PMCC-1138 PMCC-1142 PMCC-1150 PMCC-1160 PMCC-1333 PMCC-1338
BMCC-1060 BMCC-1133 BMCC-1138 BMCC-1142 BMCC-1150 BMCC-1160 BMCC-1333 BMCC-1338 BMCC-1342 BMCC-1350
MPR-TBH2 MPR-TBH3 MPR-TBH4 MPR-TBR1 MPR-TBR2 MPR-TBR3 MPR-TBR4
BMCC-1633 BMCC-1638 BMCC-1642 BMCD-0642 BMCD-0650 BMCD-0660 BMCD-0838 BMCD-0842 BMCD-0850 BMCD-0860
MPN-S030 MPN-S060 MPN-S080 MPN-S062 MPN-PA00 MPN-PA15 MPN-PA25 MPR-6105 MPR-6115 MPR-6125
MPW-S080 MPW-PA00 MPW-PA15 MPW-PA25 MPN-5100 MPN-5200 MPN-5300 MPN-5118 MPN-5218 MPN-5318
MPN-8080
CO-SB05I
MPW-5218 MPW-5318 MPW-5130 MPW-5230 MPW-5330 MPW-5145 MPW-5245 MPW-5345 MPN-6201 MPN-6202
BMCD-1642 PMCC-0642 PMCC-0650 PMCC-0660 PMCC-0838 PMCC-0842 PMCC-0850 PMCC-0860 PMCC-1033 PMCC-1038
CO-5130
MPN-SBZZ
CO-5400
MPR-SB05I
CO-SBMUI
MPN-8040D
CO-5530
MPW-SB09I
CO-5318
CO-5500
CO-5218
MPN-SPCRC
CO-5418
MPN-SSB
CO-5430
CO-5100
CO-SB13I
MPN-8060
MPW-SB05I
MPN-SB13I
MPR-SB09I
MPN-SB09I
Establishment Types
Manufacture Medical Device