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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 a medical device manufactured by Guilin Refine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-02-19 under approval 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. It is manufactured by Guilin Refine Medical Instrument Co., Ltd.. The 510(k) number is K254018.

When was Portable Dental X-ray Device (GT-1) approved by the FDA?

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

What company makes Portable Dental X-ray Device (GT-1)?

Portable Dental X-ray Device (GT-1) is manufactured by Guilin Refine Medical Instrument Co., Ltd..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41523432 Development of a Low-Cost Portable Iontophoresis Device. Cureus (2025)

Other Devices by Guilin Refine Medical Instrument Co., Ltd.

K230641Ultrasonic Scaler Tips K223414Curing Light, Model: MaxCure 9

Related Devices (Code: 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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