Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dental CT Scanner AXR

K-Number: K223816 · 2023-04-07

ApplicantAlliage S/A Industrias Medico Odontológica
Decision Date2023-04-07
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dental CT Scanner AXR is the device name listed in this FDA 510(k) record. The listed applicant is Alliage S/A Industrias Medico Odontológica. It received FDA 510(k) clearance on 2023-04-07 under 510(k) 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. The listed applicant is Alliage S/A Industrias Medico Odontológica. The 510(k) number is K223816.

When did Dental CT Scanner AXR receive FDA 510(k) clearance?

Dental CT Scanner AXR received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223816.

Who is the listed applicant for Dental CT Scanner AXR?

The FDA 510(k) record lists Alliage S/A Industrias Medico Odontológica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental CT Scanner AXR?

The FDA product code for Dental CT Scanner AXR is OAS.

Other records listing Alliage S/A Industrias Medico Odontológica as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210820EAGLE EDGE AXR90 and AXR120

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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.

↑