VarseoSmile Crown plus— 510(k) K201668

Name: FDA 510(k) clearance K201668
Creator: U.S. Food and Drug Administration
Published: 2020-06-23

Substantially Equivalent

Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG

FDA 510(k) clearance K201668 for VarseoSmile Crown plus, Substantially Equivalent on 2020-06-23. Applicant: Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2020-06-19
Decision date: 2020-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bremen, 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.