FDA.reportPublic FDA data

CORTEX DENTAL IMPLANTS INDUSTRIES LTD.

Matched from indexed company URL: Cortex, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30078426723007842672CORTEX DENTAL IMPLANTS INDUSTRIES LTD.1N2026-01-01Yaara Street 26, P.O. Box 125, Old Industrial area Shlomi Northern IL 2283202
30087067073008706707CORTEX MANUFACTURING, LLC1N2026-01-017753 Highway 72 Byhalia MS US 38611
30136279703013627970Cortex, Inc.1N2026-01-012755 Great America Way Ste 401 Santa Clara CA US 95054
30142939553014293955Cortex USA Inc.1Y2026-01-0130 Two Bridges road Suite 370 Fairfield NJ US 07004
30378738643037873864CORTEX METABOLIC INC.1Y2026-01-01126 Cuscowilla Dr Eatonton GA US 31024

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3497331983044086K993641METALYZER, MODEL 2; METALYZER, MODEL 3BTY2000-12-14
3374321985661219K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)MTD2026-03-13
3374322057359194K251344OptiMap™ SystemDQK2025-05-28
3374321947407564K230008Ablamap® SystemDQK2023-06-08
3374321587374106K223666Ablacath™ Mapping CatheterMTD2023-03-17
1075051822558891K181580Cortex CAD/CAM AbutmentsNHA2019-01-29
1075052035205472K163385Cortex Dental Implant SystemDZE2017-08-29
1075051370584631K131258SATURN DENTAL IMPLANTDZE2014-03-17
1226681783612768K102506MIXED MEDIA MARKERNEU2011-01-12
1226681933419815K100267FLEXIMARC, MODEL CM-0.9-2-10-GG-LIYE2010-02-24
1075051732125506K090709CORTEX DENTAL IMPLANT SYSTEMDZE2009-07-07
3497331550996527K001631CORTEX METAMAXBZC2001-02-22
1075051009543388
1075051298450020
1075051146821977
3374321348999970
1226681466753415
3374321847900217

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE62017-08-29
MTD22026-03-13
DQK22025-05-28
NEU22011-01-12
IYE22010-02-24
NHA12019-01-29
BZC12001-02-22
BTY12000-12-14

PMN#

GUDID#

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