Cleared Traditional

SIDEXIS 4

K132773 · Sirona Dental Systems GmbH · Radiology
Dec 2013
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K132773 is an FDA 510(k) clearance for the SIDEXIS 4, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on December 11, 2013, 97 days after receiving the submission on September 5, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K132773 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2013
Decision Date December 11, 2013
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050