Not currently registered with FDA under this name
Spartan Ultrasonics, Inc.
Fenton, MO, United States. Named as applicant on 2 dental 510(k) clearances between 1999 and 2000. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 21999–2000
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Spartan Ultrasonics, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Spartan Ultrasonics, Inc. | 2 clearances | 1999–2000 | Below |
| South Korea | MFDS | Manufacturer | Spartan Ultrasonics Inc. | 2 | 1998–2003 | 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
510(k) clearances
Clearances on which FDA names Spartan Ultrasonics, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Dec 2000 | K002753 | SPARTAN A-10 | ELC Ultrasonic Scaler |
| 25 Aug 1999 | K991888 | MINIJECT | EJI Cartridge Syringe |
Some of these clearances are listed with FDA today by another company: Shenzhen Ainengke Electronics Co., Ltd. (1).
Sources
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 of the most recent filing, which can be a US agent.