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 Number: 3004443427
• FEI Number: 3004443427
• Name: Wayne Matelski
• Owner & Operator: SEPTODONT
• Contact Address: 58, RUE DU PONT DE CRETEIL SAINT MAUR DES FOSSES; CEDEX FR-NOTA 94107 FR
• US Agent:
  • Wayne Matelski
  • 202 8576340
  • Wayne.Matelski@arentfox.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1717 K Street, NW ; Washington, DC 20006 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 9610964
• FEI Number: 1000477999
• Name: Wayne Matelski
• Owner & Operator: SEPTODONT
• Contact Address: 58, RUE DU PONT DE CRETEIL SAINT MAUR DES FOSSES; CEDEX FR-NOTA 94107 FR
• US Agent:
  • Wayne Matelski
  • 202 8576340
  • wayne.matelski@arentfox.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1717 K Street, NW ; Washington, DC 20006 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 1721729
• FEI Number: 1721729
• Name: Septodont, Inc.
• Owner & Operator: Septodont
• Contact Address: 205 Granite Run Dr., Suite 150 ; Lancaster PA 17601 US
• Official Correspondent:
  • Greg Montgomery
  • x-717-2860100-6644
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 416 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 Number: 3008242564
• FEI Number: 3008242564
• Name: Septodont, Inc
• Owner & Operator: Septodont
• Contact Address: 205 Granite Run Dr., Suite 150 ; Lancaster PA 17601 US
• Official Correspondent:
  • Greg Montgomery
  • x-717-2860100-6644
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 205 Granite Run Dr., Suite 150 ; Lancaster, PA 17601 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K212283 Septodont	BioRoot Flow 0.5g, BioRoot Flow 2g	2021-09-16
PMN K870147 | FRG Septodont, Inc. [Septodont]	Sterilization Tubing	2019-08-01
PMN K870147 | FRG Septodont, Inc [Septodont]	Sterilization Tubing	2019-08-01
PMN K051291 | FXX Septodont, Inc. [Septodont]	SImply Classic Earloop Mask	2019-08-01
PMN K051291 | FXX Septodont, Inc [Septodont]	SImply Classic Earloop Mask	2019-08-01
PMN K002168 | EJI Septodont, Inc. [Septodont]	Aspiject Self-Asperating Syringe	2019-08-01
PMN K002168 | EJI Septodont, Inc [Septodont]	Aspiject Self-Asperating Syringe	2019-08-01
PMN K172839 Septodont	ENDOSOLV	2018-02-13
PMN K130601 | KIF Septodont, Inc. [Septodont]	BioRootTM RCS	2016-06-30
PMN K140132 SEPTODONT	BIODENTINE	2014-06-27
Octocaine 50 Septodont, Novocol Pharmaceutical of Canada, Inc.	Prescription Medication	2011-12-15
Octocaine 100 Septodont, Novocol Pharmaceutical of Canada, Inc.	Prescription Medication	2011-11-16
NDC 0362-9023 Septodont	Octocaine 100	2011-11-07
NDC 0362-9010 Septodont	Octocaine 50	2011-11-07
PMN K093711 SEPTODONT	RACEGEL	2010-02-17
PMN K092251 SEPTODONT	BIODENTINE	2009-10-30
PMN K063634 SEPTODONT	RTR SYRINGE	2007-05-11
PMN K032708 SEPTODONT	PLASTALGIN AND PLASTALGIN ORTHO	2003-11-20
084048 ANDA SEPTODONT		0000-00-00 00:00:00
077250 ANDA SEPTODONT		0000-00-00 00:00:00

Similar & Related FDA Registered Companies

• SEPTODONT Inc.
• Septodont SAS Specialites Septodont
• Novocol Pharmaceutical of Canada, Inc.

Related Finance Registrations

NCAGE Code	L0HT6	SEPTODONT
CAGE Code	L0HT6	SEPTODONT

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091797925	Tampico,Mexico -> Houston, Texas	AMPOULE	33 CTN
2020091797925	Tampico,Mexico -> Houston, Texas	AMPOULE	33 CTN
2020081527363	Le Havre,France -> Houston, Texas	DENTAL PRODUCTS	7 PCL
2020080834976	Le Havre,France -> Houston, Texas	DENTAL PRODUCTS HS CODE: 30.04.39.00 SMARTBUTTON DATALOGGER D1 HS CODE: 90258050	37 PCL
2020080331879	Le Havre,France -> Houston, Texas	DENTAL PRODUCTS	37 PCL
2020070113074	Le Havre,France -> Houston, Texas	DENTAL PRODUCTS HS CODE 30043900 SMARTBUTTON DATALOGGER D1 HS CODE 90288050	38 PKG
2020062023997	Le Havre,France -> Houston, Texas	DENTAL PRODUCTS 1SMARTBUTTON DATALOGGER D1 PACKED ON 37 PALLETS 1 PARCEL WITH SAMPLES	38 PKG
2020060615409	Le Havre,France -> Houston, Texas	DENTAL PRODUCTS HS CODE: 300439 SMARTBUTTON DATALOGGER D1 HS CODE: 90258020 INVOICE: 1VF162075	37 PKG
2020060112993	Le Havre,France -> Houston, Texas	DENTAL PRODUCTS HS CODE: 30043900 SMARTBUTTON DATALOGGER D1 HA CODE: 90258050 INVOICE: 1VF161905	17 PKG