Dental CT Scanner AXR
K-Number: K223816 · 2023-04-07
Decision Date2023-04-07
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Dental CT Scanner AXR is a medical device manufactured by Alliage S/A Industrias Medico Odontológica. It received FDA 510(k) clearance on 2023-04-07 under approval number K223816. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dental CT Scanner AXR?
Dental CT Scanner AXR is a medical device that received FDA 510(k) clearance on 2023-04-07. It is manufactured by Alliage S/A Industrias Medico Odontológica. The 510(k) number is K223816.
When was Dental CT Scanner AXR approved by the FDA?
Dental CT Scanner AXR received FDA 510(k) clearance on 2023-04-07, under approval number K223816.
What company makes Dental CT Scanner AXR?
Dental CT Scanner AXR is manufactured by Alliage S/A Industrias Medico Odontológica.
What is the FDA product code for Dental CT Scanner AXR?
The FDA product code for Dental CT Scanner AXR is OAS.
Related Clinical Trials
NCT07586163
Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
ACTIVE_NOT_RECRUITING
NCT07179146
A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children
COMPLETED
NCT07550179
Labial White Spot Lesions and Proximal Caries Development in Orthodontic Patients Using Clear Aligners Versus Traditional Braces.
COMPLETED
Other Devices by Alliage S/A Industrias Medico Odontológica
Related Devices (Code: OAS)
K161900HYPERION X5Cefla S.C.
K160166X-MIND triumDe Gotzen S.R.L.
K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International
K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd.
K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.
K161881PreXion3D ExcelsiorPrexion Corporation
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.