Cleared Traditional

K253909 - NeoPEX™ Pre-Mixed Obturation Paste

K253909 is an FDA 510(k) clearance for NeoPEX Pre-Mixed Obturation Paste, manufactured by NuSmile, Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K253909 · NuSmile, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
270d
Days
Class 2
Risk

K253909 is an FDA 510(k) clearance for the NeoPEX™ Pre-Mixed Obturation Paste. 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 September 4, 2026 after a review of 270 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

FDA 510(k) Submission Details - K253909

510(k) Number K253909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2025
Decision Date September 04, 2026
Days to Decision 270 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
142d slower than avg
Panel avg: 128d · This submission: 270d
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 138
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K253909.
Vioseal X
K262050 · Spident Co., Ltd. · Sep 2026
Calcium Hydroxide Temporary Filling Material (KP-Cal)
K261514 · Guilin Kevin Peter Technology Co., Ltd. · Aug 2026
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