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

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