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FDA 510(k)

Portable Dental X-ray Device (GT-1)

K-Number: K254018 · 2026-02-19

ApplicantGuilin Refine Medical Instrument Co., Ltd.
Decision Date2026-02-19
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portable Dental X-ray Device (GT-1) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Refine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K254018. 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 Device (GT-1)?

Portable Dental X-ray Device (GT-1) is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Guilin Refine Medical Instrument Co., Ltd.. The 510(k) number is K254018.

When did Portable Dental X-ray Device (GT-1) receive FDA 510(k) clearance?

Portable Dental X-ray Device (GT-1) received FDA 510(k) clearance on 2026-02-19, under 510(k) number K254018.

Who is the listed applicant for Portable Dental X-ray Device (GT-1)?

The FDA 510(k) record lists Guilin Refine Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Dental X-ray Device (GT-1)?

The FDA product code for Portable Dental X-ray Device (GT-1) is EHD.

Other records listing Guilin Refine Medical Instrument Co., Ltd. as applicant

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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.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.K242185Rextar ProRaypia 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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