PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE— 510(k) K100539

Name: FDA 510(k) clearance K100539
Creator: U.S. Food and Drug Administration
Published: 2010-06-17

Substantially Equivalent

Preventive Technologies, Inc.

FDA 510(k) clearance K100539 for PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE, Substantially Equivalent on 2010-06-17. Applicant: Preventive Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Preventive Technologies, Inc.
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 2010-02-25
Decision date: 2010-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Trial, NC, 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.