Endoform Dental Membrane— 510(k) K231305

Name: FDA 510(k) clearance K231305
Creator: U.S. Food and Drug Administration
Published: 2024-01-23

Substantially Equivalent

Aroa Biosurgery , Ltd.

FDA 510(k) clearance K231305 for Endoform Dental Membrane, Substantially Equivalent on 2024-01-23. Applicant: Aroa Biosurgery , Ltd.. Device class: 2.

Clearance details

Applicant: Aroa Biosurgery , Ltd.
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2023-05-05
Decision date: 2024-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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