K161077

Substantially Equivalent

RnD TE and RnD SE

Applicant: Apex Dental Materials, Inc.
Product code: KLE
Advisory panel: Dental
Date received: 2016-04-18
Decision date: 2017-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Zurich, IL, US

Download summary PDF View on FDA.gov ↗

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