Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)— 510(k) K230333

Name: FDA 510(k) clearance K230333
Creator: U.S. Food and Drug Administration
Published: 2023-07-24

Substantially Equivalent

Kettenbach GmbH & Co. KG

FDA 510(k) clearance K230333 for Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800), Substantially Equivalent on 2023-07-24. Applicant: Kettenbach GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Kettenbach GmbH & Co. KG
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2023-02-07
Decision date: 2023-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eschenburg, DE

Download summary PDF View on FDA.gov ↗

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