Cleared Traditional

K130312 - IROOT FM (FDA 510(k) Clearance)

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

K130312 · Innovative Bioceramix, Inc. · Dental device
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Sep 2014
Decision
588d
Days
Class 2
Risk

K130312 is an FDA 510(k) clearance for the IROOT FM. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Innovative Bioceramix, Inc. (Vancouver, Bc, CA). The FDA issued a Cleared decision on September 18, 2014 after a review of 588 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Innovative Bioceramix, Inc. devices

Submission Details

510(k) Number K130312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2013
Decision Date September 18, 2014
Days to Decision 588 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
461d slower than avg
Panel avg: 127d · This submission: 588d
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.

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