Cleared Abbreviated

Portable Dental X-Ray (AXR60 S) (K233395) - FDA 510(k) Clearance

Also marketed or referenced as:
Portable Dental X-Ray (AXR65 S)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K233395 · Alliage S/A Industrias M?dico Odontol?gica · Radiology device
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Optimized for regulatory review, auditing and printing
Jan 2024
Decision
92d
Days
Class 2
Risk

K233395 is an FDA 510(k) clearance for the Portable Dental X-Ray (AXR60 S). Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Alliage S/A Industrias M?dico Odontol?gica (Sao Paulo, BR). The FDA issued a Cleared decision on January 3, 2024 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alliage S/A Industrias M?dico Odontol?gica devices

Submission Details

510(k) Number K233395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2023
Decision Date January 03, 2024
Days to Decision 92 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 49
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