APEX UNIVERSAL ADHESIVE— 510(k) K131043

Name: FDA 510(k) clearance K131043
Creator: U.S. Food and Drug Administration
Published: 2013-09-10

Substantially Equivalent

Apex Dental Materials, Inc.

FDA 510(k) clearance K131043 for APEX UNIVERSAL ADHESIVE, Substantially Equivalent on 2013-09-10. Applicant: Apex Dental Materials, Inc.. Device class: 2.

Clearance details

Applicant: Apex Dental Materials, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2013-04-15
Decision date: 2013-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Zurich, IL, 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.