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510(k) K211799

Biodentine XP 500, Biodentine XP 200 by Septodont — Product Code KIF

K211799 is an FDA 510(k) premarket notification submitted by Septodont for the device "Biodentine XP 500, Biodentine XP 200". The FDA issued a decision of Substantially Equivalent on August 10, 2021. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Septodont has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2021
Date Received
June 10, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

Other clearances by Septodont

  • K212283 — BioRoot Flow 0.5g, BioRoot Flow 2g (September 16, 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)
  • K780003 — ENDOSOLV E (January 20, 1978)

Other clearances for product code KIF

  • K261415 — Injectable Root Canal Sealer (KP-Root SP) (June 29, 2026)
  • K253167 — Any-Paste (January 12, 2026)
  • K252890 — ZenSeal Pro (January 7, 2026)
  • K251465 — Root canal repair materials (nRoot BP) (September 25, 2025)
  • K252285 — Well-Root PT (September 19, 2025)
  • K251884 — One-Fil Putty Injectable (August 22, 2025)
  • K251390 — MTA vpt (July 3, 2025)
  • K250710 — Injectable Root Canal Bioceramic Sealer (nRoot SP) (June 11, 2025)
  • K243353 — One-Fil Putty (March 14, 2025)
  • K243546 — AH Plus Endodontic Sealer (February 13, 2025)

FDA data resources