DD cube ONE ML— 510(k) K183569

Substantially Equivalent

Dental Direkt GmbH

FDA 510(k) clearance K183569 for DD cube ONE ML, Substantially Equivalent on 2019-02-14. Applicant: Dental Direkt GmbH. Device class: 2.

Clearance details

Applicant: Dental Direkt GmbH
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2018-12-21
Decision date: 2019-02-14
Decision: Substantially Equivalent
Clearance type: Special
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.