Cleared Traditional

K132123 - TRC-PEX, RADIC-SEALER

K132123 is an FDA 510(k) clearance for TRC-PEX, manufactured by Km Corporation. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K132123 · Km Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
253d
Days
Class 2
Risk

K132123 is an FDA 510(k) clearance for the TRC-PEX, RADIC-SEALER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Km Corporation (Anaheim, US). The FDA issued a Cleared decision on March 20, 2014 after a review of 253 days - an extended review 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: 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.

FDA 510(k) Submission Details - K132123

510(k) Number K132123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2013
Decision Date March 20, 2014
Days to Decision 253 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
125d slower than avg
Panel avg: 128d · This submission: 253d
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 143
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K132123.
MTA FILLAPEX
K140247 · Angelus Industria DE Productos Odontologicos SA · Apr 2014
RETROMTA-ORTHOMTA II
K132825 · Biomta · Apr 2014
TRC-PASTE
K133716 · Km Corporation · Apr 2014
MM-SEAL
K123276 · Micro-Mega Societe Anonyme · Mar 2014
BIOROOT RCS
K130601 · Novocol, Inc. · Oct 2013
MTA CEMENTS
K130125 · S&C Polymer Silicon- Und Composite Spezialitaeten · Jul 2013
K132123 · TRC-PEX, RADIC-SEALER
Download PDF FDA Summary Km Corporation