Manufacturer registered with FDA
Quanzhou Aguru E-commerce Co., Ltd
Quanzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Quanzhou Aguru E-commerce 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 | Plaque Remover for Teeth - Tartar Remover for Teeth, Dental Calculus Remover Teeth Cleaning KitPlaque/Tartar Remover for Teeth, Dental Calculus Remover Teeth Cleaning Kit with LED Light & 5 Adjustable Modes | 2025 |
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
Quanzhou Aguru E-commerce 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: Perio-Giene (1), Micro Motors, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Jul 1993 | K921893 | COLGATE ODONTOSON ULTRASONIC SCALER | Perio-Giene | 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 |
|---|---|---|
| QUANZHOU AGURU E-COMMERCE CO., LTDFDA reg. 3042256012 | Quanzhou Fujian, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094233). 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.