Cleared Special

iRoot SP Plus (K231259) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231259 · Innovative Bioceramix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
30d
Days
Class 2
Risk

K231259 is an FDA 510(k) clearance for the iRoot SP Plus. 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 May 31, 2023 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Innovative Bioceramix, Inc. devices

Submission Details

510(k) Number K231259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date May 31, 2023
Days to Decision 30 days
Submission Type Special
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
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K231259.
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