ARTEGRAL AND POLYSTAR SELECTION— 510(k) K030588

Name: FDA 510(k) clearance K030588
Creator: U.S. Food and Drug Administration
Published: 2003-05-07

Substantially Equivalent

Merz Dental GmbH

FDA 510(k) clearance K030588 for ARTEGRAL AND POLYSTAR SELECTION, Substantially Equivalent on 2003-05-07. Applicant: Merz Dental GmbH. Device class: 2.

Clearance details

Applicant: Merz Dental GmbH
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2003-02-25
Decision date: 2003-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, 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.