Manufacturer registered with FDA
GATE DENTAL SERVICES LTD ( T/A DentalOrganiser)
Galway, Ireland. 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
- 32 registrations outside the US
- Establishments
- 1Ireland
Registered in 3 markets
Where regulators' registries name GATE DENTAL SERVICES LTD ( T/A DentalOrganiser) 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 | GATE DENTAL SERVICES LTD ( T/A DentalOrganiser) | 2 device types | — | Below |
| Australia | TGA | Manufacturer | Gate Dental Services Ltd | 1 | 2016–2016 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Gate Dental Services Ltd | 1 | 2023–2023 | 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 GATE DENTAL SERVICES LTD ( T/A DentalOrganiser) currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | BurButler | 2026 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Spandex Advanced | 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 |
|---|---|---|
| GATE DENTAL SERVICES LTDFDA reg. 3012084997 | Galway Galway(County), Ireland | Contract manufacturer, Manufacturer |
Other names on FDA records
Gate Dental Services Ltd
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052726). 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.