Cleared Traditional

ScanX Intraoral View

K170733 · Duerr Dental AG · Radiology
May 2017
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K170733 is an FDA 510(k) clearance for the ScanX Intraoral View, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Duerr Dental AG (Bietigheim-Bissingen, DE). The FDA issued a Cleared decision on May 1, 2017, 52 days after receiving the submission on March 10, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K170733 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2017
Decision Date May 01, 2017
Days to Decision 52 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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