Cleared Traditional

K251465 - Root canal repair materials (nRoot BP)

K251465 is an FDA 510(k) clearance for Root canal repair materials (nRoot BP), manufactured by Enpuno Biotechnology Co., Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K251465 · Enpuno Biotechnology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
135d
Days
Class 2
Risk

K251465 is an FDA 510(k) clearance for the Root canal repair materials (nRoot BP). Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Enpuno Biotechnology Co., Ltd. (Changsha High-Tech Development Zone Chan, CN). The FDA issued a Cleared decision on September 25, 2025 after a review of 135 days - within the typical 510(k) review window.

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 Enpuno Biotechnology Co., Ltd. devices

FDA 510(k) Submission Details - K251465

510(k) Number K251465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2025
Decision Date September 25, 2025
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
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 83
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K251465.
Any-Paste
K253167 · Mediclus Co., Ltd. · Jan 2026
ZenSeal Pro
K252890 · Kerr Corporation · Jan 2026
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
Injectable Root Canal Bioceramic Sealer (nRoot SP)
K250710 · Enpuno Co., Ltd. · Jun 2025