Cleared Traditional

K222992 - iRoot BP Root Repair Material BioAggreg...

Also marketed or referenced as:
iRoot FS Fast Set Root Repair Material iRoot BP Plus Root Repair Material

K222992 is an FDA 510(k) clearance for iRoot BP Root Repair Material BioAggreg..., manufactured by Innovative Bioceramix, Inc.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K222992 · Innovative Bioceramix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
55d
Days
Class 2
Risk

K222992 is an FDA 510(k) clearance for the iRoot BP Root Repair Material BioAggregate Paste. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Innovative Bioceramix, Inc. (Burnaby, CA). The FDA issued a Cleared decision on November 22, 2022 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innovative Bioceramix, Inc. devices

FDA 510(k) Submission Details - K222992

510(k) Number K222992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2022
Decision Date November 22, 2022
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 83
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K222992.
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