Cariescan Pro

FDA 510(k) K090598 · Cariescan , Ltd.

Substantially Equivalent

510(k) numberK090598

Submission

Device name
Cariescan Pro
Applicant
Cariescan , Ltd.
Dundee, GB
Received
March 5, 2009
Decision date
December 15, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBL – Light-Induced Fluorescence Caries Detector
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1745
Specialty
Dental

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Questions and answers

When was Cariescan Pro cleared by the FDA?

Cariescan Pro (K090598) received a 510(k) decision of Substantially Equivalent on December 15, 2009, 285 days after the submission was received.

What is the product code of K090598?

The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.