Manufacturer registered with FDA
Amden Corp.
Carson City, NV, United States. Lists 4 dental device types with FDA across 2 registered establishments.
- Device types listed
- 4
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 2Hong Kong SAR China, United States
Registered in 2 markets
Where regulators' registries name Amden Corp. 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 | Amden Corp. | 4 device types | — | Below |
| Canada | Health Canada | Registration holder | AMDEN CORPORATION | 2 | 1998–1998 | 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 Amden Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | CYBERSONICSONIC1 | 1994 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | CYBERSONICSONIC1 | 1994 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | CYBERSONICSONIC1 | 1994 |
| Tongue ScraperLCN · Class 1 | — | Maker | CYBERSONICSONIC1 | 1998 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AMDEN CORP.FDA reg. 2951277 | Carson City, NV, United States | Manufacturer, Specification developer |
| TALENTONE HONG KONG LIMITEDFDA reg. 3008328678 | Kowloon,Hong Kong, Hong Kong SAR China | Manufacturer |
Other names on FDA records
Talentone Hong Kong Limited
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9009456). 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.