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FDA 510(k)

EAGLE EDGE AXR90 and AXR120

K-Number: K210820 · 2021-08-10

ApplicantAlliage S/A Industrias Medico Odontológica
Decision Date2021-08-10
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EAGLE EDGE AXR90 and AXR120 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 2021-08-10 under 510(k) number K210820. 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 EAGLE EDGE AXR90 and AXR120?

EAGLE EDGE AXR90 and AXR120 is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is Alliage S/A Industrias Medico Odontológica. The 510(k) number is K210820.

When did EAGLE EDGE AXR90 and AXR120 receive FDA 510(k) clearance?

EAGLE EDGE AXR90 and AXR120 received FDA 510(k) clearance on 2021-08-10, under 510(k) number K210820.

Who is the listed applicant for EAGLE EDGE AXR90 and AXR120?

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 EAGLE EDGE AXR90 and AXR120?

The FDA product code for EAGLE EDGE AXR90 and AXR120 is OAS.

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

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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