Cleared Traditional

Injectable Root Canal Bioceramic Sealer (nRoot SP)

K250710 · Enpuno Co., Ltd. · Dental

Jun 2025

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K250710 is an FDA 510(k) clearance for the Injectable Root Canal Bioceramic Sealer (nRoot SP), a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Enpuno Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on June 11, 2025, 93 days after receiving the submission on March 10, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number	K250710 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2025
Decision Date	June 11, 2025
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF