Cleared Traditional

K123070 - GALILEOS FAMILY

K123070 is the FDA 510(k) clearance for GALILEOS FAMILY by Sirona Dental Systems GmbH. It is a Class 2 Radiology device (product code OAS) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

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

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

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on March 15, 2013 after a review of 165 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K123070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 107d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 89
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