Cleared Traditional

iRoot BP Root Repair Material BioAggregate Paste (K222992) - FDA 510(k) Clearance

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

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K222992.
ADSEAL Plus
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Endocem MTA Premixed Regular
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Vista BC Sealer
K221811 · Inter-Med, Inc. · Nov 2022
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
K212563 · Prevest Denpro Limited · May 2022
Injectable Root Canal Bioceramic Sealer
K212983 · Beijing C-Root Dental Medical Devices Co., Ltd. · Dec 2021