Cleared Traditional

K123070 - GALILEOS FAMILY
(FDA 510(k) Clearance)

K123070 · Sirona Dental Systems GmbH · Radiology
Mar 2013
Decision
165d
Days
Class 2
Risk

K123070 is an FDA 510(k) clearance for the GALILEOS FAMILY. This device is classified as a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS).

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on March 15, 2013, 165 days after receiving the submission on October 1, 2012.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750. Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth..

Submission Details

510(k) Number K123070 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2012
Decision Date March 15, 2013
Days to Decision 165 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.