Portable Dental X-ray Device (GT-1)— 510(k) K254018
Substantially EquivalentGuilin Refine Medical Instrument Co., Ltd.
FDA 510(k) clearance K254018 for Portable Dental X-ray Device (GT-1), Substantially Equivalent on 2026-02-19. Applicant: Guilin Refine Medical Instrument Co., Ltd.. Device class: 2.
Summary
Guilin Refine Medical Instrument's Portable Dental X-ray Device (GT-1) is filed under product code EHD (Unit, X-Ray, Extraoral With Timer). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 872.1800. The Radiology review panel handled it as a Traditional 510(k), though the record lists Dental as the classification panel. The record flags it as a third-party review.
Guilin Refine Medical Instrument filed from Guangxi, China. The substantially equivalent decision came 66 calendar days after receipt (December 15, 2025 to February 19, 2026).
Clearance details
- Applicant
- Guilin Refine Medical Instrument Co., Ltd.
- Product code
- Product code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangxi, CN
Recent devices under product code EHD
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