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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Alliage S/A Industrias Médico Odontológica. It received FDA 510(k) clearance on 2024-01-03 under 510(k) 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. The listed applicant is Alliage S/A Industrias Médico Odontológica. The 510(k) number is K233395.

When did Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) receive FDA 510(k) clearance?

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

Who is the listed applicant for Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)?

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

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.

Related Devices (Code: EHD)

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.

K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker Medical Instrument 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.

↑