VITA LUMEX AC— 510(k) K193434

Name: FDA 510(k) clearance K193434
Creator: U.S. Food and Drug Administration
Published: 2020-07-21

Substantially Equivalent

Vita Zahnfabrik GmbH H Rauter & CO

FDA 510(k) clearance K193434 for VITA LUMEX AC, Substantially Equivalent on 2020-07-21. Applicant: Vita Zahnfabrik GmbH H Rauter & CO. Device class: 2.

Clearance details

Applicant: Vita Zahnfabrik GmbH H Rauter & CO
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2019-12-11
Decision date: 2020-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bad Sackingen, 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.