DD medical polymers— 510(k) K153490

Substantially Equivalent

Dental Direkt GmbH

FDA 510(k) clearance K153490 for DD medical polymers, Substantially Equivalent on 2016-05-13. Applicant: Dental Direkt GmbH. Device class: 2.

Clearance details

Applicant: Dental Direkt GmbH
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2015-12-04
Decision date: 2016-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spenge, 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.