Cleared Traditional

K080917 - IROOT SP

K080917 is an FDA 510(k) clearance for IROOT SP, 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 8-day FDA review.

K080917 · Innovative Bioceramix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
8d
Days
Class 2
Risk

K080917 is an FDA 510(k) clearance for the IROOT SP. 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 April 9, 2008 after a review of 8 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 - K080917

510(k) Number K080917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2008
Decision Date April 09, 2008
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 128d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
JAY Y KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KIF Resin, Root Canal Filling

All 140
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K080917.
WELL-PASTE
K090992 · Vericom Co., Ltd. · Apr 2009
ROOT CANAL XR
K083062 · S & C Polymer GmbH · Mar 2009
IROOT BP, MODEL IRBP 4609
K082943 · Innovative Bioceramix, Inc. · Jan 2009
MTA ROOT CANAL SEALER
K080203 · Dentsply Interntional · Mar 2008
WELL-PEX
K080266 · Vericom Co., Ltd. · Feb 2008
MTA ADVANCED MATERIAL
K073218 · Dentsply Interntional · Jan 2008