Jade 37% Phosphoric Acid Etchant Gel— 510(k) K150696

Name: FDA 510(k) clearance K150696
Creator: U.S. Food and Drug Administration
Published: 2015-06-23

Substantially Equivalent

Dharma Research, Inc.

FDA 510(k) clearance K150696 for Jade 37% Phosphoric Acid Etchant Gel, Substantially Equivalent on 2015-06-23. Applicant: Dharma Research, Inc.. Device class: 2.

Clearance details

Applicant: Dharma Research, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2015-03-18
Decision date: 2015-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.