FLASH PENTA MB QUICK, FLASH MB QUICK— 510(k) K140602

Name: FDA 510(k) clearance K140602
Creator: U.S. Food and Drug Administration
Published: 2014-06-05

Substantially Equivalent

3M Espe AG

FDA 510(k) clearance K140602 for FLASH PENTA MB QUICK, FLASH MB QUICK, Substantially Equivalent on 2014-06-05. Applicant: 3M Espe AG. Device class: 2.

Clearance details

Applicant: 3M Espe AG
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2014-03-10
Decision date: 2014-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bavaria D-82228 Seefeld, DE

Download summary PDF View on FDA.gov ↗

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