Cleared Traditional

XIOS PLUS WALL-MODULE

K081903 · Sirona Dental Systems GmbH · Radiology
Aug 2008
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K081903 is an FDA 510(k) clearance for the XIOS PLUS WALL-MODULE, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on August 26, 2008, 54 days after receiving the submission on July 3, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K081903 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2008
Decision Date August 26, 2008
Days to Decision 54 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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