I-View Gold and Imagen Gold Dental Sensors— 510(k) K200625

Name: FDA 510(k) clearance K200625
Creator: U.S. Food and Drug Administration
Published: 2020-04-15

Substantially Equivalent

Trident S.R.L

FDA 510(k) clearance K200625 for I-View Gold and Imagen Gold Dental Sensors, Substantially Equivalent on 2020-04-15. Applicant: Trident S.R.L. Device class: 2.

Clearance details

Applicant: Trident S.R.L
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2020-03-10
Decision date: 2020-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castenedolo, IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.