Silver Fluoride Hypersensitivity Varnish— 510(k) K241041

Name: FDA 510(k) clearance K241041
Creator: U.S. Food and Drug Administration
Published: 2025-02-28

Substantially Equivalent

Young Dental Manufacturing Co. 1, LLC

FDA 510(k) clearance K241041 for Silver Fluoride Hypersensitivity Varnish, Substantially Equivalent on 2025-02-28. Applicant: Young Dental Manufacturing Co. 1, LLC. Device class: 2.

Clearance details

Applicant: Young Dental Manufacturing Co. 1, LLC
Product code: Code PHR
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2024-04-16
Decision date: 2025-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Earth City, MO, US

Download summary PDF View on FDA.gov ↗

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