Septodont

FDA Filings

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

FDA Registration(s)
Registration Number3004443427
FEI Number3004443427
NameWayne Matelski
Owner & OperatorSEPTODONT
Contact Address58, RUE DU PONT DE CRETEIL SAINT MAUR DES FOSSES
CEDEX FR-NOTA 94107 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1717 K Street, NW
Washington, DC 20006 US
Establishment TypeManufacture Medical Device



Registration Number9610964
FEI Number1000477999
NameWayne Matelski
Owner & OperatorSEPTODONT
Contact Address58, RUE DU PONT DE CRETEIL SAINT MAUR DES FOSSES
CEDEX FR-NOTA 94107 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1717 K Street, NW
Washington, DC 20006 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number1721729
FEI Number1721729
NameSeptodont, Inc.
Owner & OperatorSeptodont
Contact Address205 Granite Run Dr., Suite 150
Lancaster PA 17601 US
Official Correspondent
  • Greg Montgomery
  • x-717-2860100-6644
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address416 S Taylor Ave
LOUISVILLE, CO 80027 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device



Registration Number3008242564
FEI Number3008242564
NameSeptodont, Inc
Owner & OperatorSeptodont
Contact Address205 Granite Run Dr., Suite 150
Lancaster PA 17601 US
Official Correspondent
  • Greg Montgomery
  • x-717-2860100-6644
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address205 Granite Run Dr., Suite 150
Lancaster, PA 17601 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Septodont
BioRoot Flow 0.5g, BioRoot Flow 2g2021-09-16
Septodont, Inc. [Septodont]
Sterilization Tubing2019-08-01
Septodont, Inc [Septodont]
Sterilization Tubing2019-08-01
Septodont, Inc. [Septodont]
SImply Classic Earloop Mask2019-08-01
Septodont, Inc [Septodont]
SImply Classic Earloop Mask2019-08-01
Septodont, Inc. [Septodont]
Aspiject Self-Asperating Syringe2019-08-01
Septodont, Inc [Septodont]
Aspiject Self-Asperating Syringe2019-08-01
Septodont
ENDOSOLV2018-02-13
Septodont, Inc. [Septodont]
BioRootTM RCS2016-06-30
SEPTODONT
BIODENTINE2014-06-27
Septodont, Novocol Pharmaceutical of Canada, Inc.
Prescription Medication2011-12-15
Septodont, Novocol Pharmaceutical of Canada, Inc.
Prescription Medication2011-11-16
Septodont
Octocaine 1002011-11-07
Septodont
Octocaine 502011-11-07
SEPTODONT
RACEGEL2010-02-17
SEPTODONT
BIODENTINE2009-10-30
SEPTODONT
RTR SYRINGE2007-05-11
SEPTODONT
PLASTALGIN AND PLASTALGIN ORTHO2003-11-20
SEPTODONT
0000-00-00 00:00:00
SEPTODONT
0000-00-00 00:00:00

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE CodeL0HT6SEPTODONT
CAGE CodeL0HT6SEPTODONT
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091797925Tampico,Mexico -> Houston, TexasAMPOULE33 CTN
2020091797925Tampico,Mexico -> Houston, TexasAMPOULE33 CTN
2020081527363Le Havre,France -> Houston, TexasDENTAL PRODUCTS7 PCL
2020080834976Le Havre,France -> Houston, TexasDENTAL PRODUCTS HS CODE: 30.04.39.00 SMARTBUTTON DATALOGGER D1 HS CODE: 9025805037 PCL
2020080331879Le Havre,France -> Houston, TexasDENTAL PRODUCTS37 PCL
2020070113074Le Havre,France -> Houston, TexasDENTAL PRODUCTS HS CODE 30043900 SMARTBUTTON DATALOGGER D1 HS CODE 9028805038 PKG
2020062023997Le Havre,France -> Houston, TexasDENTAL PRODUCTS 1SMARTBUTTON DATALOGGER D1 PACKED ON 37 PALLETS 1 PARCEL WITH SAMPLES38 PKG
2020060615409Le Havre,France -> Houston, TexasDENTAL PRODUCTS HS CODE: 300439 SMARTBUTTON DATALOGGER D1 HS CODE: 90258020 INVOICE: 1VF16207537 PKG
2020060112993Le Havre,France -> Houston, TexasDENTAL PRODUCTS HS CODE: 30043900 SMARTBUTTON DATALOGGER D1 HA CODE: 90258050 INVOICE: 1VF16190517 PKG

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