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510(k) K211799

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

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

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  • 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)

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