Cleared Traditional

K181917 - MTA2.3 MATERIALS

K181917 is the FDA 510(k) clearance for MTA2.3 MATERIALS by NuSmile, Ltd.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K181917 · NuSmile, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all NuSmile, Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 127d · 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 74
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K181917.
CeraSeal
K190503 · Meta Biomed Co., Ltd. · Jun 2019
Diapex Plus
K182625 · DiaDent Group International · Jun 2019
GuttaSil
K190510 · Meta Biomed Co., Ltd. · May 2019
BIO-C TEMP
K180199 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2019
Sonendo Material A
K181922 · Sonendo, Inc. · Oct 2018
BIO-C REPAIR
K180185 · Angelus Industria DE Produtos Odontologicos S/A · Aug 2018