iRoot BP Root Repair Material BioAggregate Paste +2 more— 510(k) K222992

Name: FDA 510(k) clearance K222992
Creator: U.S. Food and Drug Administration
Published: 2022-11-22

Substantially Equivalent

Innovative Bioceramix, Inc.

FDA 510(k) clearance K222992 for iRoot BP Root Repair Material BioAggregate Paste +2 more, Substantially Equivalent on 2022-11-22. Applicant: Innovative Bioceramix, Inc.. Device class: 2.

Clearance details

Device name as filed: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
Applicant: Innovative Bioceramix, Inc.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2022-09-28
Decision date: 2022-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

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K262050 — Vioseal X2026-09-11
K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

More clearances from Innovative Bioceramix, Inc.

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K231259 — iRoot SP Plus2023-05-31
K130312 — IROOT FM2014-09-18
K102867 — IROOT FS2010-12-03
K092715 — IROOT BP PLUS2009-09-28
K082943 — IROOT BP, MODEL IRBP 46092009-01-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.