Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)— 510(k) K240304

Name: FDA 510(k) clearance K240304
Creator: U.S. Food and Drug Administration
Published: 2024-05-28

Substantially Equivalent

Enpuno Biotechnology Co., Ltd.

FDA 510(k) clearance K240304 for Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5), Substantially Equivalent on 2024-05-28. Applicant: Enpuno Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Enpuno Biotechnology Co., Ltd.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2024-02-02
Decision date: 2024-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha High-Tech Development Zone Chan, CN

Download summary PDF View on FDA.gov ↗

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