coDiagnostiX— 510(k) K193301

Substantially Equivalent

Dental Wings GmbH

FDA 510(k) clearance K193301 for coDiagnostiX, Substantially Equivalent on 2021-06-21. Applicant: Dental Wings GmbH. Device class: 2.

Clearance details

Applicant: Dental Wings GmbH
Product code: Code DZJ
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2019-11-29
Decision date: 2021-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chemnitz, 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.