Manufacturer registered with FDA
Specialized Care Company
Hampton, NH, 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
- 24 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Specialized Care Company 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 | Specialized Care Company | 2 device types | — | Below |
| Australia | TGA | Manufacturer | Specialized Care Company | 4 | 2014–2018 | 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 Specialized Care Company 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 | SURROUND TOOTHBRUSH | 2006 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | CORBIN HVE Adapter | 2021 |
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 |
|---|---|---|
| SPECIALIZED CARE CO INCFDA reg. 3003346810 | HAMPTON, NH, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9089320). 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.