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510(k) K222992

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material by Innovative Bioceramix, Inc. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2022
Date Received
September 28, 2022
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 Innovative Bioceramix, Inc.

  • K231259 — iRoot SP Plus (May 31, 2023)
  • K130312 — IROOT FM (September 18, 2014)
  • K102867 — IROOT FS (December 3, 2010)
  • K092715 — IROOT BP PLUS (September 28, 2009)
  • K082943 — IROOT BP, MODEL IRBP 4609 (January 6, 2009)
  • K080917 — IROOT SP (April 9, 2008)
  • K063422 — BIOAGGREGATE (November 21, 2006)

Other clearances for product code KIF

  • 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)
  • K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (December 12, 2024)