Cleared Traditional

K102575 - ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)

K102575 is an FDA 510(k) clearance for ORTHO MTA (MINERAL TRIOXIDE AGGREGATE), manufactured by Do Co., Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K102575 · Do Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
51d
Days
Class 2
Risk

K102575 is an FDA 510(k) clearance for the ORTHO MTA (MINERAL TRIOXIDE AGGREGATE). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Do Co., Ltd. (Anaheim, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 51 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 Do Co., Ltd. devices

FDA 510(k) Submission Details - K102575

510(k) Number K102575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2010
Decision Date October 29, 2010
Days to Decision 51 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
76d faster than avg
Panel avg: 127d · This submission: 51d
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 K102575.
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
Well-Root ST
K170950 · Vericom Co., Ltd. · Dec 2017
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015
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