Injectable Root Canal Bioceramic Sealer (nRoot SP)— 510(k) K250710

Name: FDA 510(k) clearance K250710
Creator: U.S. Food and Drug Administration
Published: 2025-06-11

Substantially Equivalent

Enpuno Co., Ltd.

FDA 510(k) clearance K250710 for Injectable Root Canal Bioceramic Sealer (nRoot SP), Substantially Equivalent on 2025-06-11. Applicant: Enpuno Co., Ltd.. Device class: 2.

Clearance details

Applicant: Enpuno Co., Ltd.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2025-03-10
Decision date: 2025-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

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K253167 — Any-Paste2026-01-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.