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510(k) K760799

FLUOCAL GEL ORANGE by Septodont, Inc.

K760799 is an FDA 510(k) premarket notification submitted by Septodont, Inc. for the device "FLUOCAL GEL ORANGE". The FDA issued a decision of Substantially Equivalent on Nov 24, 1976. Septodont, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 24, 1976
Date Received
Oct 8, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Septodont, Inc.

  • K212283 — BioRoot Flow 0.5g, BioRoot Flow 2g (Sep 16, 2021)
  • K211799 — Biodentine XP 500, Biodentine XP 200 (Aug 10, 2021)
  • K172839 — ENDOSOLV (Feb 13, 2018)
  • K140132 — BIODENTINE (Jun 27, 2014)
  • K093711 — RACEGEL (Feb 17, 2010)
  • K092251 — BIODENTINE (Oct 30, 2009)
  • K063634 — RTR SYRINGE (May 11, 2007)
  • K051010 — SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (May 2, 2005)
  • K032708 — PLASTALGIN AND PLASTALGIN ORTHO (Nov 20, 2003)
  • K023976 — ACROSEAL ROOT CANAL OR APICAL SEALER (Jan 30, 2003)

FDA data resources