Manufacturer registered with FDA
Intersurgical Ltd.
BERKSHIRE, United Kingdom. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6267 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 6 markets
Where regulators' registries name Intersurgical Ltd. 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 | Intersurgical Ltd. | 1 device types | — | Below |
| Brazil | ANVISA | Manufacturer | INTERSURGICAL LTD. | 127 | 2023–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | INTERSURGICAL LIMITEDINTERSURGICAL LTD | 63 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | INTERSURGICAL LIMITEDINTERSURGICAL LTD · I NTERSURGICAL LIMITED | 42 | 2003–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INTERSURGICAL LTDINTERSURGICAL LIMITED · Intersurgical Ltd. · +1 | 32 | 2006–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Intersurgical Ltd. | 3 | — | 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 Intersurgical 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | OroCare Mini toothbrush, 3011000 | 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 |
|---|---|---|
| INTERSURGICAL LTD.FDA reg. 3002807267 | WOKINGHAM, BERKSHIRE, United Kingdom | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9037658). 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.