510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080917Substantially Equivalent

Iroot Sp

Innovative BioCeramix, Inc, Vancouver, Bc, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080917 is the FDA 510(k) clearance record for IROOT SP, a class II device, cleared for Innovative Bioceramix, Inc. on under FDA product code KIF (Resin, Root Canal Filling). FDA records list 8 510(k) clearances for Innovative Bioceramix, Inc., from to . As of , FDA records show no recalls naming K080917.

Clearance record

Decision date
Received
(8 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Innovative Bioceramix, Inc. 1628 W. 75th Ave., Vancouver, Bc, CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code KIF

Trailing 12 months
6 clearances under product code KIF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20262
October 20260