Manufacturer registered with FDA
Shenzhen Ainengke Electronics Co., Ltd.
Shenzhen, China. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Shenzhen Ainengke Electronics Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shenzhen Ainengke Electronics Co., Ltd. | 8 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shenzhen Ainengke Electronics Co., Ltd. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Shenzhen Ainengke Electronics 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 |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Curwy Moon Electric Teeth CleanerRELACS 7000, Plaque remover for teeth, Tartar Remover for Teeth, Teeth Cleaning Kit, 5 Modes with 3 tips, with LED LightSPARTAN A-10 Plaque Remover for Teeth, Tartar Remover Kit, Dental Cleaning Tools | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dental mirro | 2025 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | electric teeth cleaner: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9household dental cleaner: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9 | 2024 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Jacquette Scaler | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | electric teeth cleaner: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9;Flat head, pointed end; toothbrush,powerd: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9 | 2024 |
| Tongue ScraperLCN · Class 1 | — | Maker | scraper | 2025 |
| Battery-Powered Ionic ToothbrushMMD · Class 1 | Toothbrushes | Maker | PLUSTRON ION TOOTHBRUSH SYSTEM, A-10 Plaque Remover for Teeth, Tartar Remover Kit, Dental Cleaning Tools | 2026 |
| Powered Tongue ScraperQIA · Class 1 | — | Maker | Household Tooth Polisher: X1Pro, X2Pro, X3Pro, X4Pro, X5Pro, X6Pro, X7Pro, X8Pro, X9Pro, X10Pro, X11Pro, X12Pro | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Shenzhen Ainengke Electronics Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Spartan Ultrasonics, Inc. (1), Sas Group, Inc. (1), Micro-Mega Societe Anonyme (1), Micro Motors, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Dec 2000 | K002753 | SPARTAN A-10 | Spartan Ultrasonics, Inc. | ELC Ultrasonic Scaler |
| 24 Jun 1997 | K971639 | PLUSTRON ION TOOTHBRUSH SYSTEM | Sas Group, Inc. | MMD Battery-Powered Ionic Toothbrush |
| 12 May 1995 | K951272 | RELACS 7000 | Micro-Mega Societe Anonyme | ELC Ultrasonic Scaler |
| 16 Apr 1991 | K903298 | DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP | Micro Motors, Inc. | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN AINENGKE ELECTRONICS CO, LTDFDA reg. 3033858988 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091785). 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.