Cleared Traditional

K080203 - MTA ROOT CANAL SEALER

K080203 is an FDA 510(k) clearance for MTA ROOT CANAL SEALER, manufactured by Dentsply Interntional. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K080203 · Dentsply Interntional · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
58d
Days
Class 2
Risk

K080203 is an FDA 510(k) clearance for the MTA ROOT CANAL SEALER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Dentsply Interntional (York, US). The FDA issued a Cleared decision on March 26, 2008 after a review of 58 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 Dentsply Interntional devices

FDA 510(k) Submission Details - K080203

510(k) Number K080203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2008
Decision Date March 26, 2008
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
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 96
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K080203.
REALSEAL XT SEALER
K102163 · Kerr Corporation · Oct 2010
WELL-PASTE
K090992 · Vericom Co., Ltd. · Apr 2009
ROOT CANAL XR
K083062 · S & C Polymer GmbH · Mar 2009
WELL-PEX
K080266 · Vericom Co., Ltd. · Feb 2008
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
K063856 · Essential Dental Systems, Inc. · Feb 2007