Manufacturer registered with FDA
Onlycare Inc.
Denver, CO, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Onlycare 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 | Manufacturer | Onlycare Inc. | 2 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | ONLYCARE INC | 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 Onlycare Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric toothbrush, model: ET01,ET02,ET03,ET04,ET05,ET06,ET07,ET08,ET09,ET10 | 2025 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Electric dental floss, model: ED01,ED02,ED03,ED04,ED05,ED06,ED07,ED08,ED09,ED10 | 2025 |
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 |
|---|---|---|
| ONLYCARE INCFDA reg. 3035374295 | Denver, CO, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092480). 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.