Injectable Root Canal Bioceramic Sealer (i-MTA SP)— 510(k) K241977

Name: FDA 510(k) clearance K241977
Creator: U.S. Food and Drug Administration
Published: 2024-10-03

Substantially Equivalent

Longly Biotechnology (Wuhan) Co., Ltd.

FDA 510(k) clearance K241977 for Injectable Root Canal Bioceramic Sealer (i-MTA SP), Substantially Equivalent on 2024-10-03. Applicant: Longly Biotechnology (Wuhan) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Longly Biotechnology (Wuhan) Co., Ltd.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2024-07-05
Decision date: 2024-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, 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.