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FDA 510(k)

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)

K-Number: K233395 · 2024-01-03

ApplicantAlliage S/A Industrias Médico Odontológica
Decision Date2024-01-03
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) is a medical device manufactured by Alliage S/A Industrias Médico Odontológica. It received FDA 510(k) clearance on 2024-01-03 under approval number K233395. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)?

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) is a medical device that received FDA 510(k) clearance on 2024-01-03. It is manufactured by Alliage S/A Industrias Médico Odontológica. The 510(k) number is K233395.

When was Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) approved by the FDA?

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) received FDA 510(k) clearance on 2024-01-03, under approval number K233395.

What company makes Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)?

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) is manufactured by Alliage S/A Industrias Médico Odontológica.

What is the FDA product code for Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)?

The FDA product code for Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) is EHD.

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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.

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