K112168

Substantially Equivalent

COMPONEER

Applicant: Coltene/Whaledent AG
Product code: EBF
Advisory panel: Dental
Date received: 2011-07-28
Decision date: 2011-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cuyahoga Falls, OH, US

Download summary PDF View on FDA.gov ↗

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