Manufacturer registered with FDA
Cortex Dental Implants Industries Ltd.
Shlomi, Israel. Lists 5 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 367
- 510(k) clearances
- 42009–2019
- Markets registered in
- 1090 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2000–2026
Registered in 10 markets
Where regulators' registries name Cortex Dental Implants Industries Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: IsraelOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Cortex Dental Implants Industries Ltd. | 4 clearances | 2009–2019 | Below |
| European Union | EUDAMED | Manufacturer | Cortex Dental Implants Industries Ltd. | 20 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CORTEX DENTAL IMPLANTS INDUSTRIES LTD.Cortex Dental Implants Industries Ltd. | 12 | 2009–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Cortex Dental Implants Industries Ltd. | 10 | — | Pure Global AI |
| Israel | AMAR | Registration holder | Cortex Dental implants Industries LtdCortex Dental Implants Industries Ltd | 10 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Cortex Dental Implants Industries LTD | 9 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | CORTEX- DENTAL IMPLANTS INDUSTRIES LTD | 8 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CORTEX DENTAL IMPLANTS INDUSTRIES LTD.CORTEX - DENTAL IMPLANTS INDUSTRIES LTD. | 8 | 2018–2018 | Pure Global AI |
| Australia | TGA | Manufacturer | Cortex Dental Implants Industries Ltd | 7 | 2022–2022 | Pure Global AI |
| China | NMPA | Registration holder | 科特斯牙科种植体工业有限公司Cortex Dental Implants Industries Ltd. | 6 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Cortex Dental Implants Industries Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | BCDL-0833 BCDL-0838 BCDL-0842 BCDL-1033 BCDL-1038 BCDL-1042 MPN-S010 MPW-S010 MPR-0055 MPR-0070 MPW-S006ABCDL-1133 BCDL-1138 BCDL-1142 BCDL-1333 BCDL-1338 BCDL-1342 BCDL-1633 BCDL-1638 BCDL-1642BCO-CC309 BCO-CC409 BCO-CC509 BCO-CC218 BCO-CC318 BCO-CC418 BCO-CC518 BCO-CC230 BCO-CC330 BCO-CC430BCO-CC530 PCO-CC209 PCO-CC309 PCO-CC409 PCO-CC509 PCO-CC218 PCO-CC318 PCO-CC418 PCO-CC518 PCO-CC230BCO-MU218 BCO-MU318 BCO-MU418 BCO-MU518 BCO-MU230 BCO-MU330 BCO-MU430 BCO-MU530 PCO-MU209 PCO-MU309BCO-MU230 BCO-MU309 BCO-MU318 BCO-MU330 BCO-MU409 BCO-MU418 BCO-MU430 BCO-MU509 BCO-MU518 BCO-MU530BCO-MUS1 BCO-MUS2 BCO-MUS3 BCO-MUS4 BCO-MUS5 BCO-MUS6 PCO-MU209 PCO-MU218 PCO-MU230 PCO-MU309BCO-MUS1 BCO-MUS2 BCO-MUS3 BCO-MUS4 BCO-MUS5 BCO-MUS6 PCO-MUS1 PCO-MUS2 PCO-MUS3 PCO-MUS4BCSC-0642 BCSC-0650 BCSC-0660 BCSC-0838 BCSC-0842 BCSC-0850 BCSC-0860 BCSC-1033 BCSC-1038 BCSC-1042BCSC-1050 BCSC-1060 BCSC-1133 BCSC-1138 BCSC-1142 BCSC-1150 BCSC-1160 BCSC-1333 BCSC-1338 BCSC-1342 153 moreBCSC-1350 BCSC-1360 BCSC-1633 BCSC-1638 BCSC-1642 PCSC-0642 PCSC-0650 PCSC-0660 PCSC-0838 PCSC-0842BCSD-0642 BCSD-0650 BCSD-0660 BCSD-0838 BCSD-0842 BCSD-0850 BCSD-0860 BCSD-1033 BCSD-1038 BCSD-1042BCSD-1050 BCSD-1060 BCSD-1133 BCSD-1138 BCSD-1142 BCSD-1150 BCSD-1160 BCSD-1333 BCSD-1338 BCSD-1342BCSD-1350 BCSD-1360 BCSD-1633 BCSD-1638 BCSD-1642 PCSD-0642 PCSD-0650 PCSD-0660 PCSD-0838 PCSD-0842BMCC-0650 BMCC-0660 BMCC-0838 BMCC-0842 BMCC-0850 BMCC-0860 BMCC-1033 BMCC-1038 BMCC-1042 BMCC-1050BMCC-1060 BMCC-1133 BMCC-1138 BMCC-1142 BMCC-1150 BMCC-1160 BMCC-1333 BMCC-1338 BMCC-1342 BMCC-1350BMCC-1633 BMCC-1638 BMCC-1642 BMCD-0642 BMCD-0650 BMCD-0660 BMCD-0838 BMCD-0842 BMCD-0850 BMCD-0860BMCD-1030 BMCD-1033 BMCD-1038 BMCD-1042 BMCD-1050 BMCD-1060 BMCD-1130 BMCD-1133 BMCD-1138 BMCD-1142BMCD-1150 BMCD-1160 BMCD-1330 BMCD-1333 BMCD-1338 BMCD-1342 BMCD-1350 BMCD-1630 BMCD-1633 BMCD-1638 BMCC-0642BMCD-1642 PMCC-0642 PMCC-0650 PMCC-0660 PMCC-0838 PMCC-0842 PMCC-0850 PMCC-0860 PMCC-1033 PMCC-1038BST-0838 BST-0842 BST-1038 BST-1042 BST-1138 BST-1142 BST-1338 BST-1342 BST-1638 BST-1642CD-1001 CD-5003 CD-5010 CD-5020 CO-6021 CO-6022 CO-6030 CO-6020CM-0031CM-0041CO-0620CO-0621CO-0622CO-0630CO-5100CO-5130CO-5200CO-5218CO-5230CO-5300CO-5318CO-5400CO-5418CO-5430CO-5500CO-5518CO-5530CO-6125 CO-6605 CO-6606 CO-8000 CO-8015 CO-8025 CO-8029 CO-8030 CO-8031 CO-8032CO-6205 CO-6206 CO-B2380 CO-B3380 CO-B4380 CO-B5380 PCO-0209 PCO-0309 PCO-0409 PCO-0509CO-7102CCO-7103CCO-7104CCO-7105CCO-7106CCO-7107CCO-7505 CO-7506 CO-8102 CO-8103 CO-8104 CO-8105 CO-8106 CO-8107 CO-MUCHC BCO-CC209CO-8000CCO-8028CO-8033 CO-8036 CO-8037 CO-8100 CO-8111 CO-8112 CO-8113 CO-8114 CO-8115 CO-8125CO-8060CCO-8065 CO-8070 CO-8075 CO-8080 CO-8085 CO-CCADP CO-CCAIH CO-CCASR CO-CCATR CO-CCT28CO-8065CCO-8080CCO-8085CCO-8100CCO-8130 CO-8200 CO-9001 CO-9002 CO-9003 CO-9004 CO-9115 CO-9125 CO-9215 CO-9225CO-8901 CO-8902 CO-8903 CO-8910 CO-8911 CO-8912 CO-8913 CO-AA001 CO-AA002 CO-AA003CO-9001CCO-9002CCO-9003CCO-9004CCO-9115CCO-9125CCO-9215CCO-9225CCO-9315 CO-9325 CO-9415 CO-9425 CO-9700 C0-9701 CO-9705 CO-9710 CO-9711 CO-8900CO-9315CCO-9325CCO-9415CCO-9425CCO-9701CCO-9711CCO-AA001CCO-AA002CCO-AA003CCO-AA151 CO-AA152 CO-AA153 CO-AA251 CO-AA252 CO-AA253 CO-PA001 CO-PA002 CO-PA003 CO-PA151CO-AA151CCO-AA152CCO-AA153CCO-AA251CCO-AA252CCO-AA253CCO-CCAS0 CO-CCAS1 CO-CCAS2 CO-CCAS3 CO-CCAS4 CO-CCAS5 CO-6201 CO-6202 CO-6203 CO-6204CO-MUS20 CO-MUS65 CO-MUSCA CO-MUA09 CO-MUA18 CO-MUA30 BCO-MU209 BCO-MU309 BCO-MU409 BCO-MU509CO-PA003CCO-PA151 CO-PA153 CO-PA251 CO-PA252 CO-PA253 CO-MUC20 CO-MUC30 CO-MUC40 CO-MUC50 CO-MUCPLCO-S030 CO-S040 CO-S060 CO-S061 CO-S062 CO-S070 CS-0010 CS-8060 CS-8065CO-SB05ICO-SB09ICO-SB13ICO-SBMUICO-SBZZ CO-SPCRC CO-TBCRC CO-TBCRCR CO-TBH1 CO-TBH2 CO-TBH3 CO-TBH4 CO-TBR1 CO-TBR2CO-TBH1CCO-TBH2CCO-TBH3CCO-TBH4CCO-TBR1CCO-TBR2CCO-TBR3 CO-TBR4 MPN-TBCRC MPN-TBCRCR MPN-TBH1 MPN-TBH2 MPW-TBR4 MU-LTSST MU-STSST MU-S010 MU-SSBCO-TBR3CCO-TBR4CCortex CAD/CAM AbutmentsCP-1030 CP-1033 CP-1130 CP-1133 CP-1330 CP-1333 CP-1630 CP-1633 BCO-MU209 BCO-MU218MCT-N207 MCT-N210 MCT-N215 MCT-N220 MCT-R207 MCT-R210 MCT-R215 MCT-R220 MCT-W207 MCT-W210 MCT-W215 MCT-W220MPN-5130 MPN-5230 MPN-5330 MPN-5145 MPN-5245 MPN-5345 MPW-5100 MPW-5200 MPW-5300 MPW-5118MPN-6203 MPN-6204 MPN-6205 MPR-6201 MPR-6202 MPR-6203 MPR-6204 MPR-6205 MPR-6206 MPR-6207MPN-8040 CO-SBMU MPW-8040D MPW-SBZZ MPW-SPCRCMPN-8040DMPN-8060MPN-8080MPN-8104 MPN-8105 MPN-8106 MPN-8107 MPR-7102 MPR-7103 MPR-7104 MPR-7105 MPR-7106 MPR-7107MPN-8115 MPN-8125 MPN-9001 MPN-9002 MPN-9003 MPN-9004 MPN-9115 MPN-9125MPN-9215 MPN-9225 MPN-9315 MPN-9325 MPN-9415 MPN-9425 MPN-9700 MPN-9701 MPN-9710 MPN-9711MPN-S030 MPN-S060 MPN-S080 MPN-S062 MPN-PA00 MPN-PA15 MPN-PA25 MPR-6105 MPR-6115 MPR-6125MPN-SB05IMPN-SB09IMPN-SB13IMPN-SBZZMPN-SPCRCMPN-SSBMPN-TBH3 MPN-TBR1 MPN-TBR2 MPN-TBR3 MPR-TBCRC MPR-TBCRCR MPR-TBH1 MPR-SBZZ MPR-SPCRC MPR-SSBMPR-8000 MPR-8036 MPR-8040 MPR-8060 MPR-8080 MPR-8085 MPR-8115 MPR-8125 MPR-9001 MPR-9002MPR-9003 MPR-9004 MPR-9115 MPR-9125 MPR-9215 MPR-9225 MPR-9315 MPR-9325 MPR-9415 MPR-9425MPR-9700 MPR-9701 MPR-9710 MPR-9711 MPR-S010 MPR-S030 MPR-S040 MPR-S060 MPR-S080 MPR-S085 MPR-PA00MPR-PA15 MPR-PA25 MPW-6105 MPW-6115 MPW-6125 MPW-8000 MPW-8036MPR-SB05IMPR-SB09IMPR-SB13IMPR-TBH2 MPR-TBH3 MPR-TBH4 MPR-TBR1 MPR-TBR2 MPR-TBR3 MPR-TBR4MPW-5218 MPW-5318 MPW-5130 MPW-5230 MPW-5330 MPW-5145 MPW-5245 MPW-5345 MPN-6201 MPN-6202MPW-6201 MPW-6202 MPW-6203 MPW-6204 MPW-6205 MPW-6206 MPW-8040 MU-S020 MU-50HC MU-5060MPW-7503 MPW-7504 MPW-7505 MPW-7506 MPW-7605 MPW-7607 MPR-S070 MPR-S080 MPR-S085 MPW-S060 MPW-S080 MPR-S010MPW-8040 MPW-8060 MPW-8080MPW-8115 MPW-8125 MPW-9001 MPW-9002 MPW-9003 MPW-9004 MPW-9115 MPW-9125 MPW-9215 MPW-9225MPW-9315 MPW-9325 MPW-9415 MPW-9425 MPW-9700 MPW-9701 MPW-9710 MPW-9711 MPW-S030 MPW-S060MPW-S080 MPW-PA00 MPW-PA15 MPW-PA25 MPN-5100 MPN-5200 MPN-5300 MPN-5118 MPN-5218 MPN-5318MPW-SB05IMPW-SB09IMPW-SB13IMPW-SSB MPW-TBCRC MPW-TBCRCR MPW-TBH1 MPW-TBH2 MPW-TBH3 MPW-TBH4 MPW-TBR1 MPW-TBR2 MPW-TBR3MU-5080 MU-S060 MU-S080 MU-8041 MU-50PL MU-50TS MU-50TL MU-50SPL MPN-8102 MPN-8103PCO-0218 PCO-0318 PCO-0418 PCO-0518 PCO-0230 PCO-0330 PCO-0430 PCO-0530 PCO-6201 PCO-6202PCO-6203 PCO-6204 PCO-6205 PCO-6206 CO-8040 CO-8047 CO-8049 CO-8050 CO-8055 CO-8060PCO-CC330 PCO-CC430 PCO-CC530 BCO-CCS0 BCO-CCS1 BCO-CCS2 BCO-CCS3 BCO-CCS4 BCO-CCS5 PCO-CCS0PCO-CCS1 PCO-CCS2 PCO-CCS3 PCO-CCS4 PCO-CCS5 CO-CCA20 CO-CCA30 CO-CCA40 CO-CCA50 CO-CCACAPCO-MU318 PCO-MU330 PCO-MU409 PCO-MU418 PCO-MU430 PCO-MU509 PCO-MU518 PCO-MU530 PCO-MUS1 PCO-MUS2 | 2009 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | BCDL-0833 BCDL-0838 BCDL-0842 BCDL-1033 BCDL-1038 BCDL-1042 MPN-S010 MPW-S010 MPR-0055 MPR-0070 MPW-S006ABCDL-1133 BCDL-1138 BCDL-1142 BCDL-1333 BCDL-1338 BCDL-1342 BCDL-1633 BCDL-1638 BCDL-1642BCO-CC309 BCO-CC409 BCO-CC509 BCO-CC218 BCO-CC318 BCO-CC418 BCO-CC518 BCO-CC230 BCO-CC330 BCO-CC430BCO-CC530 PCO-CC209 PCO-CC309 PCO-CC409 PCO-CC509 PCO-CC218 PCO-CC318 PCO-CC418 PCO-CC518 PCO-CC230BCO-MU218 BCO-MU318 BCO-MU418 BCO-MU518 BCO-MU230 BCO-MU330 BCO-MU430 BCO-MU530 PCO-MU209 PCO-MU309BCO-MU230 BCO-MU309 BCO-MU318 BCO-MU330 BCO-MU409 BCO-MU418 BCO-MU430 BCO-MU509 BCO-MU518 BCO-MU530BCO-MUS1 BCO-MUS2 BCO-MUS3 BCO-MUS4 BCO-MUS5 BCO-MUS6 PCO-MU209 PCO-MU218 PCO-MU230 PCO-MU309BCO-MUS1 BCO-MUS2 BCO-MUS3 BCO-MUS4 BCO-MUS5 BCO-MUS6 PCO-MUS1 PCO-MUS2 PCO-MUS3 PCO-MUS4BCSC-0642 BCSC-0650 BCSC-0660 BCSC-0838 BCSC-0842 BCSC-0850 BCSC-0860 BCSC-1033 BCSC-1038 BCSC-1042BCSC-1050 BCSC-1060 BCSC-1133 BCSC-1138 BCSC-1142 BCSC-1150 BCSC-1160 BCSC-1333 BCSC-1338 BCSC-1342 152 moreBCSC-1350 BCSC-1360 BCSC-1633 BCSC-1638 BCSC-1642 PCSC-0642 PCSC-0650 PCSC-0660 PCSC-0838 PCSC-0842BCSD-0642 BCSD-0650 BCSD-0660 BCSD-0838 BCSD-0842 BCSD-0850 BCSD-0860 BCSD-1033 BCSD-1038 BCSD-1042BCSD-1050 BCSD-1060 BCSD-1133 BCSD-1138 BCSD-1142 BCSD-1150 BCSD-1160 BCSD-1333 BCSD-1338 BCSD-1342BCSD-1350 BCSD-1360 BCSD-1633 BCSD-1638 BCSD-1642 PCSD-0642 PCSD-0650 PCSD-0660 PCSD-0838 PCSD-0842BMCC-0650 BMCC-0660 BMCC-0838 BMCC-0842 BMCC-0850 BMCC-0860 BMCC-1033 BMCC-1038 BMCC-1042 BMCC-1050BMCC-1060 BMCC-1133 BMCC-1138 BMCC-1142 BMCC-1150 BMCC-1160 BMCC-1333 BMCC-1338 BMCC-1342 BMCC-1350BMCC-1633 BMCC-1638 BMCC-1642 BMCD-0642 BMCD-0650 BMCD-0660 BMCD-0838 BMCD-0842 BMCD-0850 BMCD-0860BMCD-1030 BMCD-1033 BMCD-1038 BMCD-1042 BMCD-1050 BMCD-1060 BMCD-1130 BMCD-1133 BMCD-1138 BMCD-1142BMCD-1150 BMCD-1160 BMCD-1330 BMCD-1333 BMCD-1338 BMCD-1342 BMCD-1350 BMCD-1630 BMCD-1633 BMCD-1638 BMCC-0642BMCD-1642 PMCC-0642 PMCC-0650 PMCC-0660 PMCC-0838 PMCC-0842 PMCC-0850 PMCC-0860 PMCC-1033 PMCC-1038BST-0838 BST-0842 BST-1038 BST-1042 BST-1138 BST-1142 BST-1338 BST-1342 BST-1638 BST-1642CD-1001 CD-5003 CD-5010 CD-5020 CO-6021 CO-6022 CO-6030 CO-6020CM-0031CM-0041CO-0620CO-0621CO-0622CO-0630CO-5100CO-5130CO-5200CO-5218CO-5230CO-5300CO-5318CO-5400CO-5418CO-5430CO-5500CO-5518CO-5530CO-6125 CO-6605 CO-6606 CO-8000 CO-8015 CO-8025 CO-8029 CO-8030 CO-8031 CO-8032CO-6205 CO-6206 CO-B2380 CO-B3380 CO-B4380 CO-B5380 PCO-0209 PCO-0309 PCO-0409 PCO-0509CO-7102CCO-7103CCO-7104CCO-7105CCO-7106CCO-7107CCO-7505 CO-7506 CO-8102 CO-8103 CO-8104 CO-8105 CO-8106 CO-8107 CO-MUCHC BCO-CC209CO-8000CCO-8028CO-8033 CO-8036 CO-8037 CO-8100 CO-8111 CO-8112 CO-8113 CO-8114 CO-8115 CO-8125CO-8060CCO-8065 CO-8070 CO-8075 CO-8080 CO-8085 CO-CCADP CO-CCAIH CO-CCASR CO-CCATR CO-CCT28CO-8065CCO-8080CCO-8085CCO-8100CCO-8130 CO-8200 CO-9001 CO-9002 CO-9003 CO-9004 CO-9115 CO-9125 CO-9215 CO-9225CO-8901 CO-8902 CO-8903 CO-8910 CO-8911 CO-8912 CO-8913 CO-AA001 CO-AA002 CO-AA003CO-9001CCO-9002CCO-9003CCO-9004CCO-9115CCO-9125CCO-9215CCO-9225CCO-9315 CO-9325 CO-9415 CO-9425 CO-9700 C0-9701 CO-9705 CO-9710 CO-9711 CO-8900CO-9315CCO-9325CCO-9415CCO-9425CCO-9701CCO-9711CCO-AA001CCO-AA002CCO-AA003CCO-AA151 CO-AA152 CO-AA153 CO-AA251 CO-AA252 CO-AA253 CO-PA001 CO-PA002 CO-PA003 CO-PA151CO-AA151CCO-AA152CCO-AA153CCO-AA251CCO-AA252CCO-AA253CCO-CCAS0 CO-CCAS1 CO-CCAS2 CO-CCAS3 CO-CCAS4 CO-CCAS5 CO-6201 CO-6202 CO-6203 CO-6204CO-MUS20 CO-MUS65 CO-MUSCA CO-MUA09 CO-MUA18 CO-MUA30 BCO-MU209 BCO-MU309 BCO-MU409 BCO-MU509CO-PA003CCO-PA151 CO-PA153 CO-PA251 CO-PA252 CO-PA253 CO-MUC20 CO-MUC30 CO-MUC40 CO-MUC50 CO-MUCPLCO-S030 CO-S040 CO-S060 CO-S061 CO-S062 CO-S070 CS-0010 CS-8060 CS-8065CO-SB05ICO-SB09ICO-SB13ICO-SBMUICO-SBZZ CO-SPCRC CO-TBCRC CO-TBCRCR CO-TBH1 CO-TBH2 CO-TBH3 CO-TBH4 CO-TBR1 CO-TBR2CO-TBH1CCO-TBH2CCO-TBH3CCO-TBH4CCO-TBR1CCO-TBR2CCO-TBR3 CO-TBR4 MPN-TBCRC MPN-TBCRCR MPN-TBH1 MPN-TBH2 MPW-TBR4 MU-LTSST MU-STSST MU-S010 MU-SSBCO-TBR3CCO-TBR4CCP-1030 CP-1033 CP-1130 CP-1133 CP-1330 CP-1333 CP-1630 CP-1633 BCO-MU209 BCO-MU218MCT-N207 MCT-N210 MCT-N215 MCT-N220 MCT-R207 MCT-R210 MCT-R215 MCT-R220 MCT-W207 MCT-W210 MCT-W215 MCT-W220MPN-5130 MPN-5230 MPN-5330 MPN-5145 MPN-5245 MPN-5345 MPW-5100 MPW-5200 MPW-5300 MPW-5118MPN-6203 MPN-6204 MPN-6205 MPR-6201 MPR-6202 MPR-6203 MPR-6204 MPR-6205 MPR-6206 MPR-6207MPN-8040 CO-SBMU MPW-8040D MPW-SBZZ MPW-SPCRCMPN-8040DMPN-8060MPN-8080MPN-8104 MPN-8105 MPN-8106 MPN-8107 MPR-7102 MPR-7103 MPR-7104 MPR-7105 MPR-7106 MPR-7107MPN-8115 MPN-8125 MPN-9001 MPN-9002 MPN-9003 MPN-9004 MPN-9115 MPN-9125MPN-9215 MPN-9225 MPN-9315 MPN-9325 MPN-9415 MPN-9425 MPN-9700 MPN-9701 MPN-9710 MPN-9711MPN-S030 MPN-S060 MPN-S080 MPN-S062 MPN-PA00 MPN-PA15 MPN-PA25 MPR-6105 MPR-6115 MPR-6125MPN-SB05IMPN-SB09IMPN-SB13IMPN-SBZZMPN-SPCRCMPN-SSBMPN-TBH3 MPN-TBR1 MPN-TBR2 MPN-TBR3 MPR-TBCRC MPR-TBCRCR MPR-TBH1 MPR-SBZZ MPR-SPCRC MPR-SSBMPR-8000 MPR-8036 MPR-8040 MPR-8060 MPR-8080 MPR-8085 MPR-8115 MPR-8125 MPR-9001 MPR-9002MPR-9003 MPR-9004 MPR-9115 MPR-9125 MPR-9215 MPR-9225 MPR-9315 MPR-9325 MPR-9415 MPR-9425MPR-9700 MPR-9701 MPR-9710 MPR-9711 MPR-S010 MPR-S030 MPR-S040 MPR-S060 MPR-S080 MPR-S085 MPR-PA00MPR-PA15 MPR-PA25 MPW-6105 MPW-6115 MPW-6125 MPW-8000 MPW-8036MPR-SB05IMPR-SB09IMPR-SB13IMPR-TBH2 MPR-TBH3 MPR-TBH4 MPR-TBR1 MPR-TBR2 MPR-TBR3 MPR-TBR4MPW-5218 MPW-5318 MPW-5130 MPW-5230 MPW-5330 MPW-5145 MPW-5245 MPW-5345 MPN-6201 MPN-6202MPW-6201 MPW-6202 MPW-6203 MPW-6204 MPW-6205 MPW-6206 MPW-8040 MU-S020 MU-50HC MU-5060MPW-7503 MPW-7504 MPW-7505 MPW-7506 MPW-7605 MPW-7607 MPR-S070 MPR-S080 MPR-S085 MPW-S060 MPW-S080 MPR-S010MPW-8040 MPW-8060 MPW-8080MPW-8115 MPW-8125 MPW-9001 MPW-9002 MPW-9003 MPW-9004 MPW-9115 MPW-9125 MPW-9215 MPW-9225MPW-9315 MPW-9325 MPW-9415 MPW-9425 MPW-9700 MPW-9701 MPW-9710 MPW-9711 MPW-S030 MPW-S060MPW-S080 MPW-PA00 MPW-PA15 MPW-PA25 MPN-5100 MPN-5200 MPN-5300 MPN-5118 MPN-5218 MPN-5318MPW-SB05IMPW-SB09IMPW-SB13IMPW-SSB MPW-TBCRC MPW-TBCRCR MPW-TBH1 MPW-TBH2 MPW-TBH3 MPW-TBH4 MPW-TBR1 MPW-TBR2 MPW-TBR3MU-5080 MU-S060 MU-S080 MU-8041 MU-50PL MU-50TS MU-50TL MU-50SPL MPN-8102 MPN-8103PCO-0218 PCO-0318 PCO-0418 PCO-0518 PCO-0230 PCO-0330 PCO-0430 PCO-0530 PCO-6201 PCO-6202PCO-6203 PCO-6204 PCO-6205 PCO-6206 CO-8040 CO-8047 CO-8049 CO-8050 CO-8055 CO-8060PCO-CC330 PCO-CC430 PCO-CC530 BCO-CCS0 BCO-CCS1 BCO-CCS2 BCO-CCS3 BCO-CCS4 BCO-CCS5 PCO-CCS0PCO-CCS1 PCO-CCS2 PCO-CCS3 PCO-CCS4 PCO-CCS5 CO-CCA20 CO-CCA30 CO-CCA40 CO-CCA50 CO-CCACAPCO-MU318 PCO-MU330 PCO-MU409 PCO-MU418 PCO-MU430 PCO-MU509 PCO-MU518 PCO-MU530 PCO-MUS1 PCO-MUS2PCO-MU409 PCO-MU509 PCO-MU218 PCO-MU318 PCO-MU418 PCO-MU518 PCO-MU230 PCO-MU330 PCO-MU430 PCO-MU530 | 2009 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | CD-0206CD-0208CD-0210 CD-0211 CD-0213 CD-0216 CD-2806 CD-2808 CD-2810 CD-2811 CD-2813 CD-2816CD-1001 CD-5003 CD-5010 CD-5020 CD-5025 CD-5030 CD-5040 CD-5045 CD-5050 CD-5060CD-3206 CD-3208 CD-3210 CD-3211 CD-3213 CD-3706 CD-3708 CD-3710 CD-3711 CD-3713CD-4306 CD-4308 CD-4310 CD-4311 CD-4313 CD-GS0822 CD-GS0828 CD-GS0834 CD-GS0837 CD-GS0841CD-5065 CD-5110 CD-5120 CD-5140 CD-5148 CD-5137 CD-6003 CD-6010 CD-6020 CD-6025CD-6030 CD-6040 CD-6050 CD-6060 CD-C038 CD-C042 CD-C050 CD-C060 CD-S1003 CD-S5003CD-GS1001 CD-GS1022 CD-GS1028 CD-GS1034 CD-GS1037 CD-GS1041 CD-GS1122 CD-GS1128 CD-GS1134 CD-GS1137CD-GS1141 CD-GS1322 CD-GS1328 CD-GS1334 CD-GS1337 CD-GS1341 CD-GS1622 CD-GS1628 CD-GS1634 CD-GS1637 22 moreCD-GS1641 CD-GSFP CD-GSST52 CD-GSTCC CD-GSTCH CD-GSTFL CD-GSTPCD-S5010 CD-S5020 CD-S5025 CD-S5030 CD-S5040 CD-S5045 CD-S5050 CD-S5055 CD-S5060 CD-S5065CK-GS11CK-GSPSCO-8040DCO-GS5090CO-GS7000CO-GSCLCO-GSFPSLCO-GSMN CO-GSPS CO-GSS200 CO-GSSL3 CO-GSSL CT-FPDA CT-GS262 CT-GS400 CT-GS440 CT-GSFP CT-GSL262CT-GSS440 CT-GSSPRING DO-ABUTP DO-ABUTT DO-ABUTZ DO-BRIDGEP DO-BRIDGEZ DO-CROWNP DO-CROWNZ DO-CUTBRZMPN-GS5090MPN-GS7000MPN-GSCLMPN-GSPSMPN-GSS200MPR-8040DMPR-GS5090MPR-GS7000MPR-GSCLMPR-GSS200MU-8041D | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | CK-0042CT-0242 CT-0250 CT-0252 CT-0254 CT-0260 CT-0262 CT-S262 CT-0410 CT-0413 CT-0500 CK-0062 CT-S218CT-0510 CT-0510C CT-0580 CT-0710 CT-0801 CT-0861 CT-0862 CT-0863 CT-0900 CT-H210CT-H210 CT-H215 CT-H220 CT-D210 CT-D215 CT-D220 CK-0009 CK-0010 CK-0060 CK-0061CT-MU00CT-MU01CT-MU02CT-MUP00 CT-MUP09 CT-MUP18 CT-MUP30 CK-0011 CK-0011-T CK-0015 CK-0015-T CK-0022 CK-0022-TCT-S107 CT-S110 CT-S115 CT-S207 CT-S210 CT-S215 CT-0220 CT-0230 CT-0231 CT-0232 | 2011 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | CORSCAN Digital Intraoral Scanner system | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Cortex Dental Implants Industries Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Jan 2019 | K181580 | Cortex CAD/CAM Abutments | NHA Endosseous Dental Implant Abutment |
| 29 Aug 2017 | K163385 | Cortex Dental Implant System | DZE Root-Form Endosseous Implant |
| 17 Mar 2014 | K131258 | SATURN DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 7 Jul 2009 | K090709 | CORTEX DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CORTEX DENTAL IMPLANTS INDUSTRIES LTD.FDA reg. 3007842672 | Shlomi Northern, Israel | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030174). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.