Cleared Traditional

K181917 - MTA2.3 MATERIALS (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181917 · NuSmile, Ltd. · Dental device
Jan 2019
Decision
178d
Days
Class 2
Risk

K181917 is an FDA 510(k) clearance for the MTA2.3 MATERIALS. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by NuSmile, Ltd. (Houston, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 178 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.

Submission Details

510(k) Number K181917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2018
Decision Date January 11, 2019
Days to Decision 178 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 158d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K181917.
Any-Paste
K253167 · Mediclus Co., Ltd. · Jan 2026
ZenSeal Pro
K252890 · Kerr Corporation · Jan 2026
Root canal repair materials (nRoot BP)
K251465 · Enpuno Biotechnology Co., Ltd. · Sep 2025
Well-Root PT
K252285 · Vericom Co., Ltd. · Sep 2025
One-Fil Putty Injectable
K251884 · Mediclus Co., Ltd. · Aug 2025
MTA vpt
K251390 · Voco GmbH · Jul 2025