CARIESCAN PRO— 510(k) K090598

Substantially Equivalent

Cariescan , Ltd.

FDA 510(k) clearance K090598 for CARIESCAN PRO, Substantially Equivalent on 2009-12-15. Applicant: Cariescan , Ltd.. Device class: 2.

Clearance details

Applicant: Cariescan , Ltd.
Product code: Code NBL
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2009-03-05
Decision date: 2009-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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