Manufacturer registered with FDA
Shenzhen Micro Electric Intelligence Co., Ltd.
Shenzhen, China. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 12
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1United States
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Shenzhen Micro Electric Intelligence 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | WD-XY-C01,WD-XY-C02,WD-XY-C03,WD-XY-C04,WD-XY-C05 | 2025 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Ultrasonic ScalerWD-JY-A005, WD-JY-H009, WD-JY-10011, WD-JY-K0012,WD-JY-G004, WD-JY-C006, WD-JY-M0014, WD-JY-N0015,WD-JY-K0013, WD-JY-K0014, WD-JY-K0015, WD-JY-K0016WD-JY-L0013, WD-JY-L0014, WD-JY-L0015, WD-JY-L0016,WD-JY-L0017WD-JY-N0016, WD-JY-N0017,WD-JY-E007, WD-JY-F008WD-JY-W001, WD-JY-B002, WD-JY-R003, WD-JY-B003, | 2025 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Dental calculus remover;with LED Light & 5 Modes, Rechargeable Dental Cleaner,Plaque Remover for Teeth,Dental Cleaning Kit Tartar Remover for Teeth,UItrasonic Electric Dental Scaler4 Replaceable Heads,WD-JY-W001 | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | WD-YS-B01,WD-JY-B02,WD-JY-B03,WD-JY-B04,WD-JY-B05 | 2025 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | — | 2025 |
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 Shenzhen Micro Electric Intelligence Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Jul 2024 | K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN MICRO ELECTRIC INTELLIGENCE CO., LTD.FDA reg. 3018975080 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093098). 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.