Cleared Traditional

K082943 - IROOT BP

K082943 is an FDA 510(k) clearance for IROOT BP, 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 96-day FDA review.

K082943 · Innovative Bioceramix, Inc. · Dental device
Download Printable Device Report (PDF)
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Jan 2009
Decision
96d
Days
Class 2
Risk

K082943 is an FDA 510(k) clearance for the IROOT BP, MODEL IRBP 4609. 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 January 6, 2009 after a review of 96 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Bioceramix, Inc. devices

FDA 510(k) Submission Details - K082943

510(k) Number K082943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2008
Decision Date January 06, 2009
Days to Decision 96 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
31d faster than avg
Panel avg: 127d · This submission: 96d
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 84
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K082943.
BIO-C SEALER
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CZ-S2000
K060946 · Parkell, Inc. · Jun 2006
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004