PARAPOST PARACORE AUTOMIX 5ML— 510(k) K052820

Name: FDA 510(k) clearance K052820
Creator: U.S. Food and Drug Administration
Published: 2006-01-09

Substantially Equivalent

Coltene/Whaledent AG

FDA 510(k) clearance K052820 for PARAPOST PARACORE AUTOMIX 5ML, Substantially Equivalent on 2006-01-09. Applicant: Coltene/Whaledent AG. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2005-10-04
Decision date: 2006-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.