Portable Dental X-ray Device (GT-1)— 510(k) K254018

Name: FDA 510(k) clearance K254018
Creator: U.S. Food and Drug Administration
Published: 2026-02-19

Substantially Equivalent

Guilin 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.

Clearance details

Applicant: Guilin Refine Medical Instrument Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2025-12-15
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangxi, CN

Download summary PDF View on FDA.gov ↗

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