COPRA TEMP PMMA-DISK— 510(k) K131664

Name: FDA 510(k) clearance K131664
Creator: U.S. Food and Drug Administration
Published: 2013-12-18

Substantially Equivalent

White Peaks Dental Systems GmbH & Co. KG

FDA 510(k) clearance K131664 for COPRA TEMP PMMA-DISK, Substantially Equivalent on 2013-12-18. Applicant: White Peaks Dental Systems GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: White Peaks Dental Systems GmbH & Co. KG
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2013-06-07
Decision date: 2013-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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