Cleared Traditional

K133054 - ENDOSEAL

K133054 is an FDA 510(k) clearance for ENDOSEAL, manufactured by Maruchi. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K133054 · Maruchi · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
227d
Days
Class 2
Risk

K133054 is an FDA 510(k) clearance for the ENDOSEAL. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Maruchi (Fullerton, US). The FDA issued a Cleared decision on May 12, 2014 after a review of 227 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.

View all Maruchi devices

FDA 510(k) Submission Details - K133054

510(k) Number K133054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2013
Decision Date May 12, 2014
Days to Decision 227 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
100d slower than avg
Panel avg: 127d · This submission: 227d
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 K133054.
ENDOSOLV
K172839 · Septodont · Feb 2018
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015
REALSEAL XT SEALER
K102163 · Kerr Corporation · Oct 2010
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
CZ-S2000
K060946 · Parkell, Inc. · Jun 2006