IROOT BP, MODEL IRBP 4609— 510(k) K082943

Name: FDA 510(k) clearance K082943
Creator: U.S. Food and Drug Administration
Published: 2009-01-06

Substantially Equivalent

Innovative Bioceramix, Inc.

FDA 510(k) clearance K082943 for IROOT BP, MODEL IRBP 4609, Substantially Equivalent on 2009-01-06. Applicant: Innovative Bioceramix, Inc.. Device class: 2.

Clearance details

Applicant: Innovative Bioceramix, Inc.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2008-10-02
Decision date: 2009-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, Bc, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

view all

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.

view all

K231259 — iRoot SP Plus2023-05-31
K222992 — iRoot BP Root Repair Material BioAggregate Paste +2 more2022-11-22
K130312 — IROOT FM2014-09-18
K102867 — IROOT FS2010-12-03
K092715 — IROOT BP PLUS2009-09-28

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