Data / Medical devices / China / Guilin Refine Medical Instrument Co., Ltd.
Guilin Refine Medical Instrument Co., Ltd.: FDA-registered device maker in Guilin Guangxi, China, 3 510(k) clearances
Guilin Refine Medical Instrument Co., Ltd. is registered with the FDA (registration 3016075921) in Guilin Guangxi, China. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 19, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016075921
- Address
- NO.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin Guangxi, China, 541004
- Owner or operator
- Guilin Refine Medical Instrument Co., LTD. (10064688)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 24, 2020
- Registered through
- 2026
- Brand names listed
- Curing Light (Model: MaxCure9), Dental Prophylaxis Powder, Model: PT-X1, PT-X2, PT-X3, PT-X6, PT-X5, PT-X7, External Oral Aerosol Suction System, Gutta Percha Obturation System, MaxFill-G, MaxFill-P, Portable Dental X-ray Device (Model: GT-1), Ultrasonic Activator (Model: VAT-3)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Suction Operatory | EBR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 19, 2026 | K254018 | Portable Dental X-ray Device (GT-1) | EHD | Substantially Equivalent | Guilin Refine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 21, 2023 | K230641 | Ultrasonic Scaler Tips | ELC | Substantially Equivalent | Guilin Refine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 15, 2023 | K223414 | Curing Light, Model: MaxCure 9 | EBZ | Substantially Equivalent | Guilin Refine Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Scaler, Ultrasonic
- All makers of Plugger, Root Canal, Endodontic
- All makers of Pick, Massaging
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of Unit, Suction Operatory
Updated February 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.