Medical Device Manufacturer · US , Washington , DC

Septodont - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2003

Recent clearances: BioRoot Flow 0.5g, BioRoot Flow 2g, Biodentine XP 500, Biodentine XP 200, ENDOSOLV

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Septodont Dental ✕

9 devices

1-9 of 9

Cleared Sep 16, 2021

BioRoot Flow 0.5g, BioRoot Flow 2g

Cleared Aug 10, 2021

Biodentine XP 500, Biodentine XP 200

Cleared Feb 13, 2018

Cleared Jun 27, 2014

Cleared Feb 17, 2010

Cleared Oct 30, 2009

Cleared May 11, 2007

Cleared May 02, 2005

SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70

Cleared Nov 20, 2003

PLASTALGIN AND PLASTALGIN ORTHO