Cleared Traditional

K123070 - GALILEOS FAMILY

K123070 is an FDA 510(k) clearance for GALILEOS FAMILY, manufactured by Sirona Dental Systems GmbH. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K123070

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.

OAS Device Classification - Class 2, Special Controls

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 128
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