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510(k) K760798

FLUOCAL GEL MINT by Septodont, Inc.

K760798 is an FDA 510(k) premarket notification submitted by Septodont, Inc. for the device "FLUOCAL GEL MINT". The FDA issued a decision of Substantially Equivalent on November 24, 1976. Septodont, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1976
Date Received
October 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 (September 16, 2021)
  • K211799 — Biodentine XP 500, Biodentine XP 200 (August 10, 2021)
  • K172839 — ENDOSOLV (February 13, 2018)
  • K140132 — BIODENTINE (June 27, 2014)
  • K093711 — RACEGEL (February 17, 2010)
  • K092251 — BIODENTINE (October 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 (November 20, 2003)
  • K023976 — ACROSEAL ROOT CANAL OR APICAL SEALER (January 30, 2003)

FDA data resources