Directa Ab

FDA Filings

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

FDA Registration(s)
Registration Number8030938
FEI Number3004586882
NameDIRECTA AB
Owner & OperatorDIRECTA AB
Contact AddressP.O.BOX 723 FINVIDS VAG 8
UPPLANDS VASBY SE-NOTA 194 27 SE
Official Correspondent
  • MALIN - KILEN
  • 46-70-8593438-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPO BOX 723 FINVIDS VAG 8
UPPLANDS VAESBY Stockholms lan [SE-01], 194 27 SE
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Directa AB
Ceramir BIC QuikCap 2024-04-05
Directa AB
Ceramir Crown & Bridge QuikMix 2024-04-05
Directa AB
Ceramir Crown & Bridge QuikCap 2024-04-05
Directa AB
Ceramir Crown & Bridge QuikMix 2024-04-05
Directa AB
Ceramir Crown & Bridge QuikMix 2024-04-05
Directa AB
CoForm 6040482022-12-15
Directa AB
CoForm 6040472022-12-15
Directa AB
CoForm 6040462022-12-15
Directa AB
CoForm 6040452022-12-15
Directa AB
CoForm 6040442022-12-15
Directa AB
CoForm 6040432022-12-15
Directa AB
CoForm 6040422022-12-15
Directa AB
CoForm 6040412022-12-15
Directa AB
CoForm 6040402022-12-15
Directa AB
CoForm 6040392022-12-15
Directa AB
CoForm 6040382022-12-15
Directa AB
CoForm 6040372022-12-15
Directa AB
CoForm 6040362022-12-15
Directa AB
CoForm 6040352022-12-15
Directa AB
CoForm 6040342022-12-15
Directa AB
FenderMate 6029942022-12-15
Directa AB
FenderMate 6029932022-12-15
Directa AB
FenderMate 6029922022-12-15
Directa AB
FenderMate 6029912022-12-15
Directa AB
FenderMate 6029902022-12-15
Directa AB
FenderMate 6028172022-12-15
Directa AB
FenderMate 6028162022-12-15
Directa AB
FenderMate 6028152022-12-15
Directa AB
FenderMate 6028132022-12-15
Directa AB
FenderWedge 6028112022-12-15
Directa AB
FenderMate 6028092022-12-15
Directa AB
FenderMate 6028082022-12-15
Directa AB
FenderMate 6028072022-12-15
Directa AB
FenderMate 6028062022-12-15
Directa AB
FenderMate 6028052022-12-15
Directa AB
FenderMate 6028042022-12-15
Directa AB
FenderWedge 6028032022-12-15
Directa AB
FenderWedge 6028022022-12-15
Directa AB
FenderWedge 6028012022-12-15
Directa AB
FenderWedge 6028002022-12-15
Directa AB
FenderMate 6027862022-12-15
Directa AB
FenderMate 6027742022-12-15
Directa AB
FenderMate 6027732022-12-15
Directa AB
FenderMate 6027722022-12-15
Directa AB
FenderMate 6027712022-12-15
Directa AB
FenderMate 6027702022-12-15
Directa AB
FenderWedge 6027542022-12-15
Directa AB
FenderWedge 6027532022-12-15
Directa AB
FenderWedge 6027522022-12-15
Directa AB
FenderWedge 6027512022-12-15
Directa AB
FenderWedge 6027502022-12-15
Directa AB
FenderWedge 6027492022-12-15
Directa AB
FenderWedge & FenderMate 6026792022-12-15
Directa AB
Directa Cheek Retractor 5115912022-12-15
Directa AB
Directa Cheek Retractor 5115902022-12-15
Directa AB
Directa Cheek Retractor 5115892022-12-15
Directa AB
Directa Cheek Retractor 5115882022-12-15
Directa AB
Directa Cheek Retractor 5115872022-12-15
Directa AB
Directa Cheek Retractor 5115862022-12-15
Directa AB
Directa Cheek Retractor 5115852022-12-15
Directa AB
Directa Cheek Retractor 5115842022-12-15
Directa AB
Directa Cheek Retractor 5115832022-12-15
Directa AB
PractiPal 1151202022-12-15
Directa AB
PractiPal 1150042022-12-15
Directa AB
PractiPal 1150032022-12-15
Directa AB
PractiPal 1150022022-12-15
Directa AB
PractiPal 1150012022-12-15
Directa AB
PractiPal 1150002022-12-15
Directa AB
Luxator 506635U2022-12-15
Directa AB
Luxator 506634U2022-12-15
Directa AB
Luxator 506633U2022-12-15
Directa AB
Luxator 506632U2022-12-15
Directa AB
Luxator 506631U2022-12-15
Directa AB
Luxator 506373U2022-12-15
Directa AB
Luxator 506372U2022-12-15
Directa AB
Luxator 506371U2022-12-15
Directa AB
Luxator 506370U2022-12-15
Directa AB
Luxator 506357U2022-12-15
Directa AB
Luxator 506356U2022-12-15
Directa AB
Luxator 506436U2022-12-15
Directa AB
Luxator 506435U2022-12-15
Directa AB
Luxator 506434U2022-12-15
Directa AB
Luxator 506433U2022-12-15
Directa AB
Luxator 506362U2022-12-15
Directa AB
Luxator 506361U2022-12-15
Directa AB
Luxator 506360U2022-12-15
Directa AB
Luxator 506359U2022-12-15
Directa AB
Luxator 506358U2022-12-15
Directa AB
Luxator 506333U2022-12-15
Directa AB
Luxator 506342U2022-12-15
Directa AB
Luxator 506343U2022-12-15
Directa AB
Luxator 506354U2022-12-15
Directa AB
Luxator 506353U2022-12-15
Directa AB
Luxator 506340U2022-12-15
Directa AB
Luxator 506341U2022-12-15
Directa AB
Luxator 506352U2022-12-15
Directa AB
Luxator 506355U2022-12-15
Directa AB
Luxator 506332U2022-12-15
Directa AB
Luxator 506331U2022-12-15
Directa AB
Luxator 506330U2022-12-15
DIRECTA AB
Etchant Gel2017-10-23
DIRECTA AB
DryDent Sublingual, DryDent Parotid2016-02-22
DIRECTA AB
Calasept, CalaseptPlus2016-02-16
DIRECTA AB
LuxatorLX handpiece2016-01-12
DIRECTA AB
LUXATOR LX HANDPIECE2015-11-24
DIRECTA AB
ProxyPal2007-11-19
DIRECTA AB
FenderMatePrime2007-11-19
DIRECTA AB
FenderMate2007-11-19
DIRECTA AB
Directa Strips2007-11-19
DIRECTA AB
Luxator? sharpening stone2002-07-11
DIRECTA AB
Luxator? brand2002-07-11
DIRECTA AB
Directa Polycarbonate Crowns2002-07-11
DIRECTA AB
ProphyCare ProphyPowder2002-07-11
DIRECTA AB
PROPHY PASTE2002-07-11
DIRECTA AB
ROTOSTAND2002-07-11
DIRECTA AB
RAINBOW RUBBER DAM FRAME2002-07-11
DIRECTA AB
RAINBOW DENTAL RUBBER DAM & PUNCH2002-07-11
DIRECTA AB
DRY-DAM2002-07-11
DIRECTA AB
ProphyCare ProphyCup2002-07-11
DIRECTA AB
ProphyCare ProphyAngle2002-07-11
DIRECTA AB
CHEEK RETRACTOR2002-07-11
DIRECTA AB
Physics Forceps and Bumper Guards2002-07-11
DIRECTA AB
FullForm Crown Forms2002-07-11
DIRECTA AB
FaciForm2002-07-11
DIRECTA AB
Crown Forms2002-07-11
DIRECTA AB
CoForm2002-07-11
DIRECTA AB
Calasept Paste Needle, CalaseptPlus Flexi-Needle, Calasept Irrigation Needle2002-07-11
DIRECTA AB
CAMO DENTAL SPLINT2002-07-11
DIRECTA AB
INSTRUMENT TRAY SYSTEM1985-08-27
DIRECTA AB
PLASTIC PINS1985-08-27
DIRECTA AB
BURN OUT POST1985-08-27
DIRECTA AB
ANCHORAGE POST1985-08-27
DIRECTA AB
Spot-it1985-08-27
DIRECTA AB
STIK'N PLACE1985-08-27
DIRECTA AB
FixyDap1985-08-27
DIRECTA AB
FenderWedge1985-08-27
DIRECTA AB
FenderPrep1985-08-27
DIRECTA AB
FRACFINDER1985-08-27
DIRECTA AB
COLOUR CODE TAPE & RINGS1985-08-27
DIRECTA AB
IWANSSON-HILDEBRANDT MEASURING DEV1985-08-27
DIRECTA AB
IWANSSON MEASURING DEVICE1985-08-27
DIRECTA AB
TRAY CLEANER1985-08-27
DIRECTA AB
AdaptaPal1985-08-27

Related Finance Registrations
NCAGE CodeA220NDIRECTA AB
NCAGE CodeS3806DIRECTA AB
CAGE CodeS3806DIRECTA AB
CAGE CodeA220NDIRECTA AB

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