Itena Clinical

FDA Filings

This page includes the latest FDA filings for Itena Clinical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010249660
FEI Number3010249660
NameAlice Coupal
Owner & OperatorITENA Clinical
Contact Address31 Avenue Georges Clemenceau
Villepinte FR-75 Paris 93420 FR
Official Correspondent
  • Jean-Francois Lujan
  • 033-145-913006-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2915 Ogletown Road suite 2012
Newark, DE 19713 US
Establishment Type
  • Foreign Private Label Distributor
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device



Registration Number3013557697
FEI Number3013557697
NameAlice Coupal
Owner & OperatorITENA Clinical
Contact Address31 Avenue Georges Clemenceau
Villepinte FR-75 Paris 93420 FR
Official Correspondent
  • Jean-Francois Lujan
  • 033-145-913006-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2915 Ogletown Road suite 2012
Newark, DE 19713 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Foreign Private Label Distributor
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
ITENA CLINICAL
MTA BIOSEAL MTA-BSEAL2022-12-01
ITENA CLINICAL
MTA BIOREP MTA-BRP5.52022-12-01
ITENA CLINICAL
MTA BIOREP MTA-BRP2.22022-12-01
ITENA CLINICAL
DENTOETCH DE-4.122022-11-10
ITENA CLINICAL
BOND ACTIVATOR DBAC-72022-11-10
ITENA CLINICAL
QUICKBOND DBQAB-102022-11-10
ITENA CLINICAL
QUICKBOND DBQAP-102022-11-10
ITENA CLINICAL
IPERBOND ULTRA IPBDUL-52022-11-10
ITENA CLINICAL
DENTOCORE BODY ECHDCBODY2022-11-10
ITENA CLINICAL
DENTOCORE DCA3-502022-11-10
ITENA CLINICAL
DENTOCORE DCB-502022-11-10
ITENA CLINICAL
DENTOCORE BODY DCBODY-502022-11-10
ITENA CLINICAL
DENTOCORE BODY DABODY1-102022-11-10
ITENA CLINICAL
DENTOCORE DCSAK12022-11-10
ITENA CLINICAL
PROVITEMP ECHPVTEMP2022-11-10
ITENA CLINICAL
OBTURYS ECHOBYS2022-11-10
ITENA CLINICAL
TOTAL C-RAM ECHTCRAM2022-11-10
ITENA CLINICAL
DENTOTEMP ECHDTP2022-11-10
ITENA CLINICAL
PREVENT SEAL ECHPVSEAL2022-11-10
ITENA CLINICAL
TOTALCEM ECHTLCEM2022-11-10
ITENA CLINICAL
OBTURYS OBAX1-52022-11-10
ITENA CLINICAL
OBTURYS OBHM1-52022-11-10
ITENA CLINICAL
TOTAL C-RAM TTCRAM-OD2022-11-10
ITENA CLINICAL
TOTAL C-RAM TTCRAM-TR2022-11-10
ITENA CLINICAL
DENTOCEM DCA-2.52022-11-10
ITENA CLINICAL
PREVENT SEAL PVSEAL-1.22022-11-10
ITENA CLINICAL
PROVITEMP PTEMP1-102022-11-10
ITENA CLINICAL
DENTOTEMP DTCA1-52022-11-10
ITENA CLINICAL
TOTALCEM TTLCEM-TR2022-11-10
ITENA CLINICAL
TOTALCEM TTLCEM-A22022-11-10
ITENA CLINICAL
REFLECTYS FLOW FWTYS-B32022-11-10
ITENA CLINICAL
REFLECTYS FLOW FWTYS-B22022-11-10
ITENA CLINICAL
REFLECTYS FLOW FWTYS-A3.52022-11-10
ITENA CLINICAL
REFLECTYS FLOW FWTYS-A32022-11-10
ITENA CLINICAL
REFLECTYS FLOW FWTYS-A22022-11-10
ITENA CLINICAL
REFLECTYS FLOW FWTYS-A12022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-P2022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-I2022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-E2022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-A3O2022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-A2O2022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-D32022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-C32022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-C22022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-B32022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-B22022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-B12022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-A42022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-A3.52022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-A32022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-A22022-11-10
ITENA CLINICAL
REFLECTYS CPTYS-A12022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-P2022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-I2022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-E2022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-A302022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-A202022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-D32022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-C32022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-C22022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-B32022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-B22022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-B12022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-A42022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-A3,52022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-A32022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-A22022-11-10
ITENA CLINICAL
REFLECTYS SRTYS-A12022-11-10
ITENA CLINICAL
Silan-IT 2022-10-26
ITENA CLINICAL
LUXITE luxite-U2022-10-19
ITENA CLINICAL
SILANEA SILSER1.2-52022-10-19
ITENA CLINICAL
DENTOCROWN DWN-A2B22021-10-29
ITENA CLINICAL
DENTOCROWN DWN-A1B12021-10-29
Itena Clinical
Obturys2017-07-31
ITENA CLINICAL
TotalC-Ram2017-03-14
ITENA CLINICAL
PROVITEMP2013-06-14
ITENA CLINICAL
PREVENT SEAL2013-06-11
ITENA CLINICAL
DENTO TEMP2013-04-26
ITENA CLINICAL
PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM2013-04-19
ITENA CLINICAL
DEUTOETCH QUICKBOND BOND ACTIRATOR2013-03-19
ITENA CLINICAL
DENTOCORE/DENTOCORE BODY2013-03-05
Itena Clinical
Otc Medication2012-12-01
Itena Clinical
Pure Snow Whitening2012-11-30

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