I View and Imagen Sensor— 510(k) K162619

Substantially Equivalent

Trident S.R.L

FDA 510(k) clearance K162619 for I View and Imagen Sensor, Substantially Equivalent on 2016-11-04. 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: 2016-09-20
Decision date: 2016-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Assago, 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.