Cleared Traditional

Root canal repair materials (nRoot BP)

K251465 · Enpuno Biotechnology Co., Ltd. · Dental

Sep 2025

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K251465 is an FDA 510(k) clearance for the Root canal repair materials (nRoot BP), a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Enpuno Biotechnology Co., Ltd. (Changsha High-Tech Development Zone Chan, CN). The FDA issued a Cleared decision on September 25, 2025, 135 days after receiving the submission on May 13, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number	K251465 FDA.gov
FDA Decision	Cleared 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