IMPRESSIX, COLORCHANGE ALGINATE— 510(k) K062400

Name: FDA 510(k) clearance K062400
Creator: U.S. Food and Drug Administration
Published: 2006-11-16

Substantially Equivalent

Cavex Holland BV

FDA 510(k) clearance K062400 for IMPRESSIX, COLORCHANGE ALGINATE, Substantially Equivalent on 2006-11-16. Applicant: Cavex Holland BV. Device class: 2.

Clearance details

Applicant: Cavex Holland BV
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2006-08-16
Decision date: 2006-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haarlem, NL

Download summary PDF View on FDA.gov ↗

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