Cleared Traditional

K251465 - Root canal repair materials (nRoot BP) (FDA 510(k) Clearance)

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

K251465 · Enpuno Biotechnology Co., Ltd. · Dental device
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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

Submission Details

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.

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 142
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