Manufacturer registered with FDA
Four D Rubber Co Ltd
HEANOR, United Kingdom. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 720 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 7 markets
Where regulators' registries name Four D Rubber Co 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 | Four D Rubber Co Ltd | 1 device types | — | Below |
| Australia | TGA | Manufacturer | Four D Rubber Co Ltd | 5 | 2005–2013 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Four D Rubber Co Ltd | 5 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Four D Rubber Company Ltd | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | FOUR D RUBBER CO., LTD.FOUR D RUBBER CO LTD. | 3 | 2015–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | FOUR D RUBBER CO LTD. | 2 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Four D Rubber Company Ltd | 1 | — | 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 Four D Rubber Co 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 |
|---|---|---|---|---|
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | ISOLATELatex BIODAMLatex ISODAMLatex Isotex Oral BarrierNon Latex BIODAMNon Latex ISODAMNon Latex IsoTex Oral BarrierPolyisoprene Dental Dam | 2009 |
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 |
|---|---|---|
| FOUR D RUBBER CO LTDFDA reg. 8021853 | HEANOR Derbyshire, United Kingdom | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029528). 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.