Portable Dental X-ray Device (GT-1)
Summary
Guilin Refine Medical Instrument Co., Ltd. received 510(k) clearance for Portable Dental X-ray Device (GT-1), a EHD device. Cleared on 2026-02-19.
Details
Source
510(k) Clearance
External ID
K254018
Action Date
2026-02-19
Status
Traditional
Category
device
Product Code
EHD
Product Description
Portable Dental X-ray Device (GT-1). Product code: EHD.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Guilin Refine Medical Instrument Co., Ltd. has received 3 total clearances in our database.
Guilin Refine Medical Instrument Co., Ltd. has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Guilin Refine Medical Instrument Co., Ltd. have FDA actions?
Guilin Refine Medical Instrument Co., Ltd. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K254018" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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