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510(k) K082943

IROOT BP, MODEL IRBP 4609 by Innovative Bioceramix, Inc. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2009
Date Received
October 2, 2008
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.

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  • K222992 — iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair M (November 22, 2022)
  • K130312 — IROOT FM (September 18, 2014)
  • K102867 — IROOT FS (December 3, 2010)
  • K092715 — IROOT BP PLUS (September 28, 2009)
  • K080917 — IROOT SP (April 9, 2008)
  • K063422 — BIOAGGREGATE (November 21, 2006)

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  • K250710 — Injectable Root Canal Bioceramic Sealer (nRoot SP) (June 11, 2025)
  • K243353 — One-Fil Putty (March 14, 2025)
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