Manufacturer registered with FDA
Guilin AestheDent Medical Instruments Co., Ltd
Guilin City, China. Lists 4 dental device types with FDA across 0 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 12025–2025
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Guilin AestheDent Medical Instruments Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Dental Implant Unit; IMPLANT surg, IMPLANT Classical | 2026 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Dental Anesthesia Injector; Anesthesia Pen X, Anesthesia Pen Mini | 2026 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | ENDO Irrigator | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Implant Electric Wrench; Implant Wrench | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Guilin AestheDent Medical Instruments Co., Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Apr 2025 | K242646 | Dental Implant Unit | EBW Handpiece and Cord Foot Controller |
Some of these clearances are listed with FDA today by another company: Guangxi Ehall Medical Technology Co.,Ltd (1).
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096508). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.