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510(k) K102867

IROOT FS by Innovative Bioceramix, Inc. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2010
Date Received
September 30, 2010
Clearance Type
Special
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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  • K130312 — IROOT FM (September 18, 2014)
  • 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)

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